MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA INTRAOCULAR LENS

Model Number	MX60E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.Based on the available information, the root cause of this event could not be determined.Bausch + lomb will continue to monitor for similar occurrences.
Event or Problem Description
It was reported that after implantation of an intraocular lens (iol) into the left eye (os), the patient complained of pain and blurry vision, which progressed day 2.Slit lamp findings on post-op day 2 were corneal edema 4+, c/s injection 4+, ac cell 3+, vitreous haze, vitreous cells 3+, and vitritis 2+.The patient's best corrected distance visual acuity (bcdva) decreased from 20/30+ (pre-op) to hand motion.Based on the findings, it was presumed to be early staph endophthalmitis.An intravitreal tap/culture was performed & injections of ceftazidime, vancomycin and dexamethasone were administered.Results of the culture were negative.The patient outcome is good.According to the doctor, the most likely cause of the event is toxic anterior segment syndrome.Medications prescribed for use at home post-operatively: pred forte q1h daytime for 1 week vigamox qid.Prolensa (directed to discontinue use (b)(6) 2024).Lotemax (directed to discontinue use (b)(6) 2024).
Additional Manufacturer Narrative
Additional information: b5, g2, g3, h2, h11.
Event or Problem Description
Additional information was received indicating that approximately seven weeks prior to implantation of the iol into the left eye, the patient had the same model lens implanted into the right eye and did not have any complications.The patient had pre-existing ocular conditions of pseudoexfoliation syndrome (pxf) and small pupil in the left eye.

• 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: 22127156
• Report Number: 0001313525-2025-00119
• Device Sequence Number: 7265931
• Product Code: HQL
• UDI-Device Identifier: 10757770531339
• UDI-Public: (01)10757770531339(17)270430(11)240514(10)3Q12802
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: MX60E
• Device Catalogue Number: MXUE2050
• Device Lot Number: 3Q12802
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/14/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female