MAUDE Adverse Event Report: AMO Puerto Rico Mfg. Inc. SENSAR IOL; Intraocular Lens

Model Number	AR40e
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Eye Injury (1845)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a three-piece non-preloaded monofocal intraocular lens (iol) was opened on the back table and the haptics were observed to be bent/kinked prior to use.A backup iol of the same model was used; however, it was implanted and subsequently removed due to positioning in the eye.The doctor then decided to perform a vitrectomy.The procedure was successfully completed using another iol of the same model.An emerald cartridge was used.No patient harm was reported.The ophthalmic viscosurgical device (ovd) and balanced salt solution (bss) used were unknown.However, it was reported that the iol was allowed to rest in the cartridge for a period of time before being handed to the doctor.No further information was provided.
Additional Manufacturer Narrative
Section d6a: if implanted, give date: not applicable, as lens was inserted and then removed in the same procedure.Section d6b: if explanted, give date: not applicable, as lens was inserted and then removed in the same procedure.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 were made to obtain the missing information; however, no additional information has been received.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 ; +1(714)247-8552
• MDR Report Key: 50849614
• Report Number: 3012236936-2026-000276
• Device Sequence Number: 9497506
• Product Code: HQL
• UDI-Device Identifier: 05050474502130
• UDI-Public: (01)05050474502130(17)300603
• Combination Product (Y/N): N
• 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): 09/22/2026

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: AR40E00215
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 275 LB
• Patient Race: White