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

Model Number	AR40E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving a three-piece monofocal non-preloaded intraocular lens (iol), resistance was encountered while inserting the cartridge, preventing advancement of the lens.Prior to implantation, when attempting to remove the lens from the cartridge, the optic was observed to be kinked and the haptic was stuck at the plunger tip and had broken.Despite this, the lens was implanted in the patient¿s left eye.Explantation of the lens was planned but had not been performed at the time of reporting.Post-operatively, the patient experienced temporary visual impairment, with best corrected visual acuity reported as 6/60, improving to 6/18 (p4).There were no reports of unplanned incision enlargement, unplanned sutures, unplanned vitrectomy, or procedural delay.No additional medical or surgical intervention beyond standard care was required.The surgeon indicated that the directions for use were followed and confirmed that there was no patient harm.No further information was provided.
Additional Manufacturer Narrative
Section a3b and a6: unknown/ not provided.Section d6b: if implanted, give date: not applicable, as there is no indication that the lens was implanted.Section d6b: if explanted, give date: not applicable, as there is no indication that the lens was implanted.Section e1: reporter: middle name: unknown/ not provided.Section e1: reporter: email address: unknown/ not provided.Section e1: reporter: address: address - line 2: unknown/ not provided.Section e1: reporter: address: state, province, or territory: unknown/ not provided.Section e1: reporter: address: 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 the device history record and complaint history for production order for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.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: 25671286
• Report Number: 3012236936-2026-000188
• Device Sequence Number: 5639151
• Product Code: HQL
• UDI-Device Identifier: 05050474502130
• UDI-Public: (01)05050474502130(17)300117
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/30/2026

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: 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: 06/05/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2025
• 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
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic