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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, and 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: not applicable; the intraocular lens was inserted and removed during the same procedure.Section d6b: explant date: not applicable; the intraocular lens was inserted and removed during the same procedure.Section e1: telephone number: (b)(6).Section h3: the device was not returned for evaluation.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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the standalone intraocular lens (iol) was in contact with the patient but the haptic felt unstable, and it was removed.Through follow-up, we learned that the lens was implanted, and subsequently removed and replaced with a lens of the same power in the same procedure.There were no patient injury reported.No further information was provided.
Additional Manufacturer Narrative
Device evaluation: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: 19-feb-2026.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection of the complaint device reveal that the lens was received coated in viscoelastic residue.The lens was cleaned and no issues were identified.The physical characteristics of the received lens was confirmed to match that of an ar40e model lens.The complaint issue "haptic damaged" could not be confirmed during product evaluation, and no issues were found.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.

• 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: 24397497
• Report Number: 3012236936-2026-000028
• Device Sequence Number: 13243570
• Product Code: HQL
• UDI-Device Identifier: 05050474502079
• UDI-Public: (01)05050474502079(17)290809
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2026

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: AR40E
• Device Catalogue Number: AR40E00185
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2024
• 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