Common use of Device Deficiencies Clause in Contracts

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: • Failure to meet product specifications (e.g., incorrect lens power/diameter/base curve/color) • Lens/solution Lens 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: • 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 performancecontamination