MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA SIMPLIFEYE INSERTER; FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)

Model Number 21987

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 12/02/2020

Event Type  Injury  

Manufacturer Narrative

According to the reporter, the device was discarded and is not available for evaluation.A review of the device history record has been performed and no anomalies or nonconformities were identified that would be associated with the reported event.The investigation is ongoing.

Event Description

It was reported that during a procedure an intraocular lens (iol) was inserted in the patient¿s eye.Upon delivery to the capsular bag it was noted that the trailing haptic had sheared off.The iol was removed from the eye by cutting with a scissors.The incision was enlarged to remove the lens.No information provided on the extent of the incision extension.The lens was replaced intraoperatively with an iol of the same model and diopter.No sutures were provided at the time of the surgery per the doctor¿s decision; however, sutures were provided due to the enlarged incision as an emergency the next day.Additional information has been requested but has not been received.Diopter.The trailing haptic on the replacement iol was torn at the trailing haptic fenestration holes.This iol remains implanted.The incision was enlarged to remove the first iol, no information provided on the extent of the incision extension.No sutures were provided at the time of the surgery; however, sutures were provided due to the enlarged incision as an emergency the next day.Additional information requested.

Manufacturer Narrative

According to the reporter, the device was discarded and is not available for evaluation.A device history record (dhr) review did not find any nonconformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for use were reviewed and considered acceptable.Based on the available information, the root cause of this event could not be conclusively determined.

• Brand Name: ENVISTA SIMPLIFEYE INSERTER
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• MDR Report Key: 11057698
• MDR Text Key: 223445521
• Report Number: 0001313525-2020-00209
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): Y
• PMA/PMN Number: K192005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 21987
• Device Lot Number: 1977C4
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL PRELOADED
• Patient Outcome(s): Required Intervention