MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number MX60PL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Excessive Tear Production (2235); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

The lens remains implanted and is not available for investigation.Additional information was requested, but not received.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.

Event Description

Reportedly a consumer experienced blurry vision immediately after implantation of an intraocular lens (iol) into her right eye.Within a year of implantation of the iol, a secondary procedure was performed.Consumer reports eye pain, discomfort, and excessive tearing.Reportedly, the surgeon would not exchange the lens at the consumer's request.Additional information has been requested, but not received.

Manufacturer Narrative

Additional info: b5, g3, h2, h10 based on additional information received, the device causality is unrelated and therefore, this event no longer meets reportability requirements and is no longer deemed reportable.

Event Description

Additional information was received, indicating the secondary procedure was due to posterior capsule opacification and is unrelated to the device.

• 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 ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 17552433
• MDR Text Key: 321220923
• Report Number: 0001313525-2023-70099
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 10757770571670
• UDI-Public: (01)10757770571670(17)230831
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: MX60PL
• Device Catalogue Number: MXUEPL2850
• Device Lot Number: 3065216
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• 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: SIMPLIFEYE INSERTER FOR ENVISTA
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female