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 Codes	Blurred Vision (2137); Visual Impairment (2138); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: historical data analysis: a search of complaints related to the production order was performed and one additional complaint was found.These complaint issues reported are not related; therefore, no further actions are required.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that a patient underwent lens exchange surgery in the left eye (os), replacing a non-johnson & johnson intraocular lens (iol) with a johnson & johnson non-preloaded three-piece iol.Following the procedure, the patient experienced persistent uncorrectable blurred vision os, despite undergoing two lens repositioning procedures on (b)(6) 2024, which did not resolve the issue.The patient claims to be unable to see out of os.Pre-existing conditions os, including macular pucker, cystoid macular edema, and glaucoma, were noted as potential contributors to the blurred vision.After the johnson & johnson lens was implanted, the patient¿s uncorrected visual acuity (va) showed significant fluctuations, ranging from hand motion on the day of the lens exchange to 20/60 by (b)(6) 2025, with corrected vision recorded at 20/50 as of (b)(6) 2025.The following uncorrected visual acuities were noted: on (b)(6) 2024 va was 20/50, on (b)(6) 2024 va was 20/200, on (b)(6) 2024 va was 20/30, on (b)(6) 2024 va was light perception.Uncorrected va after the first lens reposition were as follows: (b)(6) 2024 va was 200 at 7 feet, on (b)(6) 2024 va was 200 at 10 feet.In (b)(6) 2024, the patient¿s uncorrected va was 200 at 9 feet.The patient was referred to a retinal specialist for further evaluation, as the surgeon was unable to determine whether the issue was related to the lens or the pre-existing conditions.The johnson & johnson lens remains implanted, and no additional interventions are currently planned.No further information was provided.
Additional Manufacturer Narrative
Section a4: weight: unknown; requested but not provided.Section a5: ethnicity: unknown; requested but not provided.Section a6: race: unknown; requested but not provided.Section d6b: if explanted, give date: not applicable, as the lens remains implanted.Section h3: the device was not returned for evaluation as it 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 the review, if there is any further relevant information a supplemental medwatch will be filed.Section h6: health effect - clinical code 4581 is to capture eye anatomy issue/pre-existing disease of macular pucker, cystoid macular edema, and glaucoma.Section h6: health effect - clinical code 2137 is to capture blurry vision & visual acuity fluctuations.Section h6: health effect - clinical code 2138 is to capture visual acuity decreased & unexpected postop refraction.Attempts were made to obtain the missing information; however, no additional information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 23000492
• Report Number: 3012236936-2025-000239
• Device Sequence Number: 15819889
• Product Code: HQL
• UDI-Device Identifier: 05050474502109
• UDI-Public: (01)05050474502109(17)290408
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: AR40E
• Device Catalogue Number: AR40E00200
• 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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/22/2025
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 10/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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 Sex: Male