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	Visual Impairment (2138)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information.Section h3, device evaluated by manufacturer: the device has not been returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
Left eye manufacturer report number 3012236936-2025-0003026.It was reported that the johnson and johnson (jnj) intraocular lens (iol) was implanted into the patient¿s left eye.At the patient¿s follow-up visit the doctor determined hyperopic error.The symptoms were reported as affecting the patient ability to perform one or more daily activities.The iol is simply not the best diopter for the patient.The iol was explanted and replaced with another johnson and johnson lens model ar40e 7.5 diopter.There were no complications such as a capsule tear, vitrectomy or sutures.The patient is doing well.No further information is available.
Event or Problem Description
The iol was explanted and replaced with another johnson and johnson lens model ar40e 5.0 diopter.
Additional Manufacturer Narrative
Corrected data: in the initial report section b5 it states that the replacement lens is 7.5 diopter but should have been 5.0 diopter.Also, the doctor¿s middle initial was provided.The correction is below.Section b5 describe event or problem: the iol was explanted and replaced with another johnson and johnson lens model ar40e 5.0 diopter.Section e1, middle name: the doctor¿s middle initial was provided as ¿d¿.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional information section d9: device available for evaluation? yes section d9: date returned to manufacturer: dec 11, 2025 section h3: evaluated by manufacturer? yes device evaluation: the complaint lens was received.The lens was visually inspected revealing that the lens was cut in half and coated in viscoelastic residue, and what appears to be dried blood.The lens was cleaned and inspected, and the haptics were observed to be bent.No further issues were identified.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be verified.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: 23612897
• Report Number: 3012236936-2025-000302
• Device Sequence Number: 15970629
• Product Code: HQL
• UDI-Device Identifier: 05050474501867
• UDI-Public: (01)05050474501867(17)300728
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/30/2025

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: AR40E00040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 12/18/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/12/2025; 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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: 35 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White