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

Model Number 21987

Device Problem Use of Device Problem (1670)

Patient Problem No Code Available (3191)

Event Date 12/18/2020

Event Type  Injury  

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.In the surgeon's opinion the likely cause of the reported issue is an injector failure.The most likely root cause for this event is operational context.User-related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to this event.No corrective action is necessary at this time.

Event Description

It was reported that while implanting an intraocular lens (iol) into the patient's eye that the trailing haptic of the iol got trapped in the tip of the cartridge and broke.The surgery was complicated and the incision was enlarged from 2.2mm to 2.6mm.Sutures were needed in the cornea to ensure closure of the incision which is not the usual protocol.The surgeon considered removing the lens; however, decided against it.Currently the patient has visual acuity of 0.6, the lens is completely stable and the patient does not want a second surgery.In the surgeon's opinion the likely cause of the reported issue is an injector failure.

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.In the surgeon''s opinion the likely cause of the reported issue is an injector failure.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: 11177681
• MDR Text Key: 227034241
• Report Number: 0001313525-2021-00011
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

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: 04/30/2023
• Device Model Number: 21987
• Device Lot Number: 222
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL PL; ENVISTA IOL PL
• Patient Outcome(s): Required Intervention