MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	EE
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Visual Impairment (2138); Eye Pain (4467); Toxic Anterior Segment Syndrome (TASS) (4469); Photophobia (4801)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Additional information received from consumer indicating that approximately 10 weeks post-op they had complaints of photophobia and eye redness again; allegedly diagnosed as inflammation/toxic anterior segment syndrome (tass).A steroid drop was prescribed for seven weeks.According to the consumer the symptoms have resolved.Additional information was requested but not received.
Additional Manufacturer Narrative
Additional information: b5, e1, e2, g2, g3, h2, h6, h11.
Additional Manufacturer Narrative
The device remains implanted.Investigation of this event is in progress.Recall of device is underway.
Event or Problem Description
It was reported that 4 days after implantation of an intraocular lens (iol) into the left eye (os), the patient complained of pain, discomfort, sensitivity to light & foggy vision.Injections of ceftazidime (2mg/0.1ml) & vancomycin (1mg/0.1ml) were administered and a culture was taken.The results of the culture were negative.Patient's best corrected visual acuity (bcva) decreased immediately post-op and throughout intervention but resolved after.In the surgeon's opinion, the most likely cause of the event is lens material.Patient outcome is good.The following medication was prescribed for use at home post-operatively: ofloxacin.
Additional Manufacturer Narrative
Additional info: g3, h2, h11.Correction: h3.

• 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: 21899988
• Report Number: 0001313525-2025-00093
• Device Sequence Number: 17165079
• Product Code: HQL
• UDI-Device Identifier: 10757770607874
• UDI-Public: (01)10757770607874(17)270930(11)241023(10)3Q28914
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Consumer,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/01/2025

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: EEU2000
• Device Lot Number: 3Q28914
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/24/2025; 05/06/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 04/24/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: B+L INJECTOR SYSTEM, AMVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female