MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. SENSAR IOL; INTRAOCULAR LENS

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Posterior Capsule Opacification (4807)
Date of Event	08/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d6b: if explanted; give date: not applicable as the device remains implanted.Section h3: the device was not returned for evaluation as the lens remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of records including device history and complaint trending will be performed.Upon completion of this review, if there is any further relevant information, a supplemental medwatch will be filed.Section h6: health effect - impact code: 4625 yag (yttrium aluminum garnet).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient was implanted with non-preloaded monofocal intraocular lenses (iols) in both eyes, with surgeries performed within a two-week interval.Yttrium-aluminum-garnet (yag) laser capsulotomy was conducted in both eyes approximately 30 days postoperatively for treatment of scar tissue, per patient report.The patient has a medical history of retinopathy, with approximately 4¿5 prior laser procedures performed in both eyes before cataract surgery.Postoperatively, the patient indicated that uncorrected vision was satisfactory; however, when using prescription eyeglasses, a persistent yellow tint was perceived, rated as 1/10 with the initial pair and 4.5/10 with a second pair of transitional lenses.The patient declined the second pair due to the same issue.The eyeglass technician also reportedly observed a slight yellow tint when viewing through the eyeglasses.The treating physician was unable to determine the cause of the yellow tint associated with glasses use.Despite overall good visual acuity, the patient reported inconvenience requiring the use of sunglasses over prescription glasses while driving.The patient elected to use clip-on/flip-up sunglasses as a management approach.No further information was provided.This report is for patient's left eye.A separate report will be submitted for the right eye.

• Brand Name: SENSAR IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 25257897
• Report Number: 3012236936-2026-000144
• Device Sequence Number: 20188329
• Product Code: HQL
• UDI-Device Identifier: 05050474502086
• UDI-Public: (01)05050474502086(17)290311
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2026

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: AR40E
• Device Catalogue Number: AR40E00190
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White