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

Model Number 21987

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vitreous Loss (2142)

Event Date 05/17/2022

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and directions for us review were considered acceptable, with the product performing within anticipated rates.Based on all available information, the root cause of this event could not be determined.

Event Description

It was reported that during an initial cataract procedure, while delivering the lens into the eye the trailing outer edge of the haptic broke off and was separated.There was some vitreous loss; and as a result the surgeon reported zonular instability.An anterior vitrectomy was required to resolve the vitreous loss.The lens was poorly centered and unstable therefore had to be removed using forceps and scissors.The incision was enlarged to remove lens fragments.A backup lens of the same model and diopter was implanted.No sutures were required, and the wound was hydrated to seal.

Manufacturer Narrative

The device was returned for evaluation.The shuttle was attached correctly to the delivery device and the plunger was advanced and did exit the injector tip.The plunger and tips did not exhibit damage.Based on the available information, user related factors (such as loading or handling techniques) and/or procedural factors (such as lens and inserter interaction) might have contributed to the event.

• Brand Name: ENVISTA SIMPLIFEYE INJECTOR
• Type of Device: FOLDERS AND INJECTORS, INTRAOCULAR LENS (IOL)
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; altenrhein CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759
• MDR Report Key: 14692649
• MDR Text Key: 294012232
• Report Number: 0001313525-2022-00072
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K192005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

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: 02/29/2024
• Device Model Number: 21987
• Device Lot Number: 222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 06/15/2022
• Supplement Dates Manufacturer Received: 06/30/2022
• Supplement Dates FDA Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ENVISTA IOL
• Patient Outcome(s): Required Intervention