Device Deficiency. Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Note: This definition includes malfunctions, use errors, and inadequate labeling. • Malfunction is defined as a failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling of the device. The intended performance of the device refers to the intended use for which the device is labeled or marketed. • Use error is defined as the act or omission of an act that results in a different medical device response than intended by manufacturer or expected by user. Examples of device deficiencies include the following: • Failure to meet product specifications (eg, incorrect IOL power) • IOL defect • Broken IOL optic • Broken IOL haptic • Scratched IOL optic • Unsealed device packaging • Suspect product contamination (IOL) • Lack of efficacy Adverse Event (AE) Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the medical device. Serious Adverse Event (SAE) Adverse event that led to any of the following: • Death • A serious deterioration in the health of the subject that either resulted in:
Device Deficiency. A device deficiency is defined in accordance with ISO 14155 as “inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance.” Device deficiencies include malfunctions, use errors, and inadequate labeling. If a device deficiency occurs, the Investigator will notify the Sponsor by email at the email address provided on the cover page of this protocol. Allergan shall review all device deficiencies and determine/document in writing whether they could have led to a SADE. These shall be reported to the regulatory authority as required by national regulations.
Device Deficiency. Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance such as malfunctions, misuse or use errors and inadequate labeling. Serious Adverse Device Effect (XXXX) – An ADE that has resulting in any of the consequences characteristic of a SAE Serious Adverse Events (SAE) - Defined as an AE that: • Led to Death • Are Life-threatening • Led to Hospitalization (in-patient or prolonged) • Resulted in Disability or Permanent Damage • Led to Fetal Distress, Fetal Death or Congenital Anomaly/Birth Defect • Required Intervention to Prevent Permanent Impairment or Damage
Device Deficiency. Any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.
