MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Reportedly during implantation of an iol, one of the haptics was cut off by the injector.The following day the lens was exchanged successfully.Additional information was requested, but not received.
Additional Manufacturer Narrative
Additional information including the device lot number was requested, but not received.The device was not available for evaluation.A dhr (device history record) review could not be performed as the lot number of the device was not provided.The trend analysis, risk analysis and/or directions for use review were considered acceptable, with the product performing within anticipated rates.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.
Additional Manufacturer Narrative
Device lot number was provided.A review of the device history record (dhr) did not find any non-conformities or anomalies related to the reported event.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.
Additional Manufacturer Narrative
The device was received for evaluation.The evaluation revealed the lens was cut into two pieces with a damaged haptic.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 INTRAOCULAR LENS
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 16511677
• Report Number: 0001313525-2023-00035
• Device Sequence Number: 12492400
• Product Code: HQL
• UDI-Device Identifier: 10757770515704
• UDI-Public: (01)10757770515704(17)230331
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: MX60
• Device Catalogue Number: MX60P3100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 05/04/2023; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female