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

Model Number 21987

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

Although requested, the device was not returned for evaluation, and additional information regarding the event was not provided.A review of device history records (dhr) did not find any non-conformities or anomalies related to this event.The lot history, trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Based on all available information, no root cause could be determined.

Event Description

It was reported that during iol implantation one of the haptics broke which resulted in the iol being unstable in the eye.Patient was referred to a second surgeon who performed an iol exchange the following week.Additional medical information has been requested but not received.

• 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
• Manufacturer (Section G): MEDICEL AG; dornierstrasse 11; alternhein CH-94 23; SZ CH-9423
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 16608960
• MDR Text Key: 311924213
• Report Number: 0001313525-2023-70040
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)280226(10)2282A1
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 21987
• Device Lot Number: 2282A1
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention