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

Model Number	AR40E
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4, and a5: unknown, as information was requested but not provided.Section d6a: if implanted, give date: n/a, as lens was removed/replaced during the same procedure.Section d6b: if explanted, give date: n/a, as lens was removed/replaced during the same procedure.Section e1 - email address: unknown/not provided.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 this review, if there is any further relevant information a supplemental medwatch will be filed.Section h6 health effect - impact code: 4625 (for sutures and incision enlarged).Section h6 -health effect - clinical code: 4581: no code available (incision enlarged).An attempt has 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 after inserting the non-preloaded intraocular lens (iol) into the patient's eye, the trailing haptic was detached.The iol was removed and the procedure was completed successfully with a replacement device.There were no patient injury reported, and no other medical intervention was required.Account indicated that during procedure the incision was enlarged and the physician sutured the wound.No further information was provided.
Additional Manufacturer Narrative
Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: december 16, 2025.Section h3 - device evaluated by manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received coated in what appeared to be blood.The lens was cleaned, revealing that a haptic was damaged.A scratch was observed on the lens.The photograph provided by the customer was evaluated.The image showed a cartridge and a lens covered in blood that appeared to have a detached haptic.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.The other observed issues could not be confirmed to be related to a manufacturing or design issue.Conclusion: based on the complaint investigation results, the product was released within specifications.No product deficiency or product malfunction could be identified.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: 23899157
• Report Number: 3012236936-2025-000328
• Device Sequence Number: 14710014
• Product Code: HQL
• UDI-Device Identifier: 05050474502109
• UDI-Public: (01)05050474502109(17)290314
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: AR40E00200
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2024
• 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