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

Model Number 21987

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/29/2022

Event Type  Injury  

Manufacturer Narrative

The device has been discarded and is not available for evaluation.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.Investigation of this event is in progress and a follow-up will be submitted upon completion of investigation.

Event Description

Reportedly during delivery of the device the leading haptic came out straight.The surgeon removed the lens and used a backup lens which had the trailing haptic snap at the optic/haptic junction.The second lens was cut and removed from the patient¿s eye.Patient left the facility aphakic and returned the next week.A new lens of unknown model and diopter was implanted with no issues.Additional information was requested but not received.This report correlates to iol 2 of 2.

Manufacturer Narrative

The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.Corrective measures have been identified to mitigate future similar occurrences.Bausch & lomb will continue to monitor similar events to determine if additional actions are required.

• 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: 16051765
• MDR Text Key: 306173656
• Report Number: 0001313525-2022-00195
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00757770547449
• UDI-Public: (01)00757770547449(17)231130(10)1977C4
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ENVISTA PRELOADED IOL.
• Patient Outcome(s): Required Intervention