MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60PL
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Blurred Vision (2137); Excessive Tear Production (2235); Eye Pain (4467)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• 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: 17552433
• Report Number: 0001313525-2023-70099
• Device Sequence Number: 6967151
• Product Code: HQL
• UDI-Device Identifier: 10757770571670
• UDI-Public: (01)10757770571670(17)230831
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 08/31/2023
• Device Model Number: MX60PL
• Device Catalogue Number: MXUEPL2850
• Device Lot Number: 3065216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SIMPLIFEYE INSERTER FOR ENVISTA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female