MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60E

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

Patient Problem Capsular Bag Tear (2639)

Event Date 11/15/2022

Event Type  Injury  

Event Description

It was reported that during implantation of an intraocular lens (iol) into the left eye the posterior capsular ruptured.The iol was removed, a vitrectomy was performed, and a successful lens exchange was performed using a backup three-piece lens of same diopter positioning the lens in the ciliary sulcus.A suture was used to close wound.Per the surgeon, the likely cause of the event is surgeon error and that the lens may have snagged the capsule and broken it.Patient outcome is good.

Manufacturer Narrative

Although requested, the device was not returned for evaluation.A review of the device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.The lot history, trend analysis, risk analysis and directions for use review were considered acceptable, with the product performing within anticipated rates.Based on the available information, the root cause of this event could not be conclusively determined; however, it is noteworthy to mention an unvalidated injector was used to complete the original implant.

• Brand Name: ENVISTA INTRAOCULAR LENS
• Type of Device: 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 ; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 15986087
• MDR Text Key: 305495603
• Report Number: 0001313525-2022-00186
• Device Sequence Number: 1
• Product Code: HQL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/15/2022

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 Model Number: MX60E
• Device Catalogue Number: MXUE2000
• Device Lot Number: 3260920
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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: 1MTEC30 INJECTOR, AMVISC, BSS
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male