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

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a non-preloaded monofocal intraocular lens (iol), model ar40e, was implanted into the patient¿s right eye.A non¿johnson & johnson needle (tsk) was used during the procedure, and the haptic broke while being sutured.The iol was subsequently cut in half and explanted during the same surgery.The procedure was completed using a backup iol of the same power.Incision enlargement, placement of a suture, a vitrectomy, and an approximate 10-minute surgical delay were reported.Additional information indicated that the patient¿s postoperative status remained stable.The complaint device was discarded.No further information was provided.
Additional Manufacturer Narrative
Section a4 and a5: unknown, information was requested but not provided.Section d6a: if implanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section d6b: if explanted, give date: not applicable, as lens was removed/replaced during the same surgery.Section h6: health effect- impact code 4631-pt-removal and replacement : procedural complications (more complex surgery) section h6: health effect- impact code 4625- pt-sutures : surgical intervention, hs-incision enlarged : procedural complications and pt-unplanned vitrectomy : surgical intervention (additional surgery) section h6: health effect- clinical code 4581-hs-incision enlarged : procedural complications (appropriate term / code not available).Section h3: the device was not returned for evaluation as it was discarded; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record and complaint trending for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Conclusion: based on the investigation, no malfunction or product deficiency was identified.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Additional Manufacturer Narrative
Corrected data: the following fields was updated based on the additional information received as the following code is no longer applicable applicable to this event: section h6: section h6: health effect- impact code 4625- additional surgery (unplanned vitrectomy).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: 24551565
• Report Number: 3012236936-2026-000060
• Device Sequence Number: 15823973
• Product Code: HQL
• UDI-Device Identifier: 05050474501881
• UDI-Public: (01)05050474501881(17)280517
• Combination Product (Y/N): N
• Initial Reporter State: GU
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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: AR40E00060
• 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: 02/12/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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 Age: 33 YR
• Patient Sex: Male
• Patient Race: Native Hawaiian Or Other Pacific Islander