MAUDE Adverse Event Report: Bausch + Lomb enVista Aspire IOL; Intraocular Lens

Model Number	EA
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Edema (1791); Hypopyon (1913); Inflammation (1932); Intraocular Pressure Increased (1937); Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469)
Date of Event	09/19/2024
Type of Reportable Event	Serious Injury
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 approximately 1.5 weeks after implantation of an intraocular lens (iol) into the left eye, the patient presented with toxic anterior segment syndrome (tass).The original surgery was complex due to pseudoexfoliation and use of malyugin ring during procedure to open pupil and the use of a ctr to aide capsular bag support.Patient outcome is is good (20/20) but the pupil is irregular from the pupil stretching.Additional information was requested, but not received.
Additional Manufacturer Narrative
Corrected d4, 6a, h7 additional information: a2 b3, b5, b6, b7, d10, h6, h11.A review of the 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 could not be conclusively determined.
Event or Problem Description
Additional information was obtained from the reporting surgeon indicating the patient presented one day post op with decreased visual acuity, anterior chamber fibrin, hypopyon, injection, corneal edema and increased post op intraocular pressure.Patient was treated with bromfenac, pred acetate, ofloxacin, and combigan.The surgeon attributes the event to the implanted iol.The patient will require a pupiloplasty.
Event or Problem Description
Additional information was obtained from the surgeon.The patient is high profile and suture was needed to reduce the risk of infection.The patient is now 20/20 unaided, manifest refraction is plano, and inflammation has resolved.

• Brand Name: enVista Aspire IOL
• 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 place blvd; clearwater, FL 33759 ; +1(727)724-6600
• MDR Report Key: 21853463
• Report Number: 0001313525-2025-00053
• Device Sequence Number: 15442390
• Product Code: HQL
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P910056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Model Number: EA
• Device Catalogue Number: EAU1950
• Device Lot Number: 3Q21111
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 04/18/2025; 05/27/2025; 08/21/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/15/2025; 06/25/2025; 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2024
• 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: MALYUGIN RING AND CTR; PROVISC
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female