MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	EE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hypopyon (1913); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	03/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 1 day after implantation of an intraocular lens (iol) into the left eye (os), fibrin in ac, 2+cell, and hypopyon about.5mm was observed.The patient's bcva decreased from 20/20 sc pod1 to 20/60 sc pod2.In the surgeon's opinion, the most likely cause of the event is tass related event.Patient outcome is good.The following medications were prescribed (for use at home post-operatively): omni combo gtts one drop os tid (b)(6) 2025), pred forte 1% one drop os q1hr (started (b)(6) 2025), moxifloxacin 0.5% one drop os tid (started (b)(6) 2025), ketorolac 0.4% one drop os qid-bid (started (b)(6) 2025), medrol dose pack.
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.

• 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 n park pl blvd; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 21864782
• Report Number: 0001313525-2025-00059
• Device Sequence Number: 4684775
• Product Code: HQL
• UDI-Device Identifier: 10757770607850
• UDI-Public: (01)10757770607850(17)271130(11)241217(10)3Q33933
• 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: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/20/2025

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 Model Number: EE
• Device Catalogue Number: EEU1900
• Device Lot Number: 3Q33933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES96594
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female