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

Model Number	AR40M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the standalone 3 piece monofocal intraocular lens (iol) had a broken haptic.A back up lens was used and there were no clinical consequences.No further detail was provided.
Additional Manufacturer Narrative
Section a5: per regulation eu 2016/679 (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d6a - implant date: n/a - lens was not implanted.Section d6b - explant date: n/a - lens was not implanted.Section e1 - telephone number: (b)(6).Device evaluation: product testing could not be performed since the device was not returned for evaluation.Therefore, the reported issue could not be verified, and no product quality deficiency could be identified.Manufacturing records review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.A search of complaints related to this production order (po) was performed.The search revealed that no additional complaints were received for this po.No escalation required.Conclusion: based on the complaint investigation results, no product deficiency or product malfunction were found.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Additional Manufacturer Narrative
Additional info: section d9: device available for evaluation? yes.Section d9: returned to manufacturer on: 11 march 2026.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside a piece of gauze.A visual inspection under magnification revealed that the lens was received coated in viscoelastic residue and fibers from the gauze it was received in.One haptic was damaged.The lens was cleaned revealing no further issues.The complaint issue "haptic damaged" was identified during product evaluation; however, based on the complaint investigation results the complaint issue could not be confirmed to be related to the manufacturing or design process.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.All pertinent information available to johnson and 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: 21869401
• Report Number: 3012236936-2025-000096
• Device Sequence Number: 15414406
• Product Code: HQL
• UDI-Device Identifier: 05050474501812
• UDI-Public: (01)05050474501812(17)290202
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40M
• Device Catalogue Number: AR40MN0010
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/18/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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
• Patient Sex: Unknown