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

Model Number	AAB00
Medical Device Problem Codes	Material Fragmentation (1261); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, and a5: patient identifiers were not collected or recorded and therefore are not available.Section d6b - explant date: not applicable - lens remains implanted.Section e1 - first/given name: unknown, as information was requested but not provided.Section e1 - last name: unknown, as information was requested but not provided.Section e1 - telephone number: unknown, as information was requested but not provided.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.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the handle (haptic) of the intraocular lens (iol) broke off.After implantation and viscoelastic washing, the haptics had difficulty separating from the optical part.Additionally, the lenses experienced difficulty passing through the cartridge.The customer indicated that there were no changes in the use of the device.There was no adverse patient outcome reported.Account indicated that the problem was observed at the moment of iol implantation.There was no resistance with this lens, but resistance has often been observed with other iols at the moment of implantation when the iol passes through the cartridge.The lens was implanted and remains in the patient's eye.The separation of the haptic from the optical part of the iol was immediately detected.The haptic elements are mostly glued to the optical part.The optical part itself has the outer edges curled towards the middle.Most often, it is necessary to mechanically separate the haptic element from the optic.In this case, the haptic element was immediately separated from the optic inside the eye.No further information was provided.A separated report will be submitted for the unknown events mentioned.
Additional Manufacturer Narrative
Corrected data: upon further review, it was noted that the sections below were addressed inappropriately in the initial mdr report.The following sections are being updated accordingly: section b5 - describe event or problem: the lens is not available for return as it was removed in pieces and replaced within the same procedure.Section h6-type of investigation: 4115 (code updated from 4117 to reflect that the lens was discarded after removal) 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: 23900888
• Report Number: 3012236936-2025-000336
• Device Sequence Number: 12009328
• Product Code: HQL
• UDI-Device Identifier: 05050474548718
• UDI-Public: (01)05050474548718(17)280904
• Combination Product (Y/N): N
• Initial Reporter Country: RS
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2025

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: AAB00
• Device Catalogue Number: AAB0000225
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2024
• 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