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

Model Number	AR40E
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during insertion into the patient's left eye, a non-preloaded monofocal intraocular lens (iol), model ar40e, failed to deploy and became stuck in the cartridge.The procedure required incision enlargement, placement of sutures, and additional medical intervention.A replacement lens of the same model and diopter was implanted.The patient¿s outcome was good, and no injury was reported.No additional information was provided.
Additional Manufacturer Narrative
Section a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, the lens was not implanted.Section d6b: if explanted, give date: not applicable, the lens was not implanted.Hence, not explanted.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.Section h6- health effect- impact code 4625-hs-incision enlarged : procedural complications section h6- health effect- impact code 4644- pt-medical intervention : interventional procedure section h6- health effect- clinical code 4581-hs-incision enlarged : procedural complications attempts has been made to obtain missing information; however, the information has not been provided.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.; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 24227694
• Report Number: 3012236936-2026-000030
• Device Sequence Number: 8971135
• Product Code: HQL
• UDI-Device Identifier: 05050474501980
• UDI-Public: (01)05050474501980(17)291010
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/30/2026

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: AR40E00140
• Was Device Available for Evaluation?: No
• 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: 01/06/2026
• Initial Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EMERALD LOT# CA30971.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown