Device Deficiencies. Safety Assessment
Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with subject harm (ie, ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The Investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any subject harm separately. Examples of device deficiencies include the following: • Failure to meet product specifications (eg, incorrect lens power/diameter/base curve/color) • Lens cloudy • Lens surface/edge defect • Torn lens during handling/in pack • Packaging deficit (eg, mislabeled product) • Suspect product contamination • Lack of performance
Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with patient harm (ie, ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The Investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any patient harm separately.
Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any patient harm separately. Examples of device deficiencies include the following: • Failure to meet product specifications (e.g., incorrect lens power/diameter/base curve/color) • Lens/solution cloudy • Lens surface/edge defect • Torn lens during handling/in pack • Packaging deficit (e.g., mislabeled product, tampered seal, leaking bottle/container) • Suspect product contamination • Lack of performance
Device Deficiencies. A device deficiency is inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. A device deficiency may or may not be associated with patient harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The investigator should determine the applicable category listed in the Device Deficiency eCRF for the identified or suspect device deficiency and report any patient harm separately. Examples of device deficiencies include the following: • Len missing/folded/fragments/Lens cloudy/dirty • Lens surface/edge defect • Torn lens during handling/in pack • Packaging deficit (e.g., blister strip damage, primary/secondary label mismatch, mislabeled product, tampered seal) • Potential contaminant
Device Deficiencies. A device deficiency may or may not be associated with subject harm (i.e., ADE or SADE); however, not all ADEs or SADEs are due to a device deficiency. The investigator should determine the applicable category for the identified or suspect device deficiency and report any subject harm separately. • Event 1 • Event 2 • Event 3, etc.
Device Deficiencies. Assess and record any device deficiencies that are reported or observed at each study visit, including those associated with changes in concomitant medication dosing since the previous visit. Requirements for reporting device deficiencies in the study can be found in Section 11. Note: AEs and device deficiencies must be recorded for all enrolled subjects from the time of signature of informed consent, regardless of subject enrollment status (screen failure or randomized). .
Device Deficiencies. The VSA app is an NSR device, but since the device does not diagnose or provide therapy, no device deficiencies are anticipated. Software bugs within the VSA app, either found by the study team or reported by the participant will not be considered a device deficiency. If, at any time during the study, the participant’s Smartphone (where the VSA app is installed) physically breaks, or malfunctions, or the VSA app ceases to function or gives unexpected or erroneous information, participants will be instructed to stop using the VSA app and contact the study team. If the participant has another compatible Smartphone, instructions on installing the VSA app on a different Smartphone will be provided and the participants will be instructed on how to remove the VSA app on the first Smartphone (if applicable). If, at any time during the study, a commercially available (i.e., FDA cleared or approved) device (PAP and associated supplies) physically breaks, or malfunctions, or gives unexpected or erroneous information, participants will be instructed to contact their DME provider. The DME provider may provide a replacement device or repairs at the sponsor’s discretion. Alternatively, the sponsor may choose to exit the participant without providing a replacement device. The sponsor will not provide maintenance or support for any commercially available (i.e., FDA cleared or approved) devices (PAP and associated supplies). If a participant reports a device malfunction and/or device complaint to the sponsor support team (Verily User Success), the participant will be instructed to contact their DME provider. The sponsor support team may contact study participants during study participation in order to troubleshoot issues with the VSA app, such as issues logging in or the app crashing.
Device Deficiencies. The number and percentage of all device deficiencies will be tabulated with a breakdown by treatment and implanted eye. A listing of all device deficiencies will also be provided. The number and percentage of all IOL observations will be tabulated with a breakdown by treatment and implanted eye. The number and percentage of eyes within each category of subjective posterior capsule opacification will be tabulated with a breakdown by treatment and implanted eye.
