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 Codes	Chemosis (1775); Corneal Edema (1791); Vitreous Loss (2142); Capsular Bag Tear (2639); Zonular Dehiscence (2698)
Date of Event	11/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: unknown/ not provided.Section d6a: if implanted, give date: not applicable, as lens was removed in the initial surgery.Section d6b: if explanted, give date: not applicable, as lens was removed in the initial surgery.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, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Section e1: telephone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that when the model ar40e intraocular lens (iol) was implanted, the lens haptic suddenly fractured.The haptic lacerated the capsule, producing an approximately 5 × 5 mm round tear in the capsule, which resulted in rupture of the zonular fibers and made iol fixation impossible.Viscoelastic was injected, the vitreous prolapsed into the anterior chamber was excised with capsular scissors, and cortical material and viscoelastic were aspirated with the irrigation/aspiration device.Carbachol 1 ml was injected to induce miosis.The wound was closed with four interrupted 10-0 nonabsorbable sutures.The patient was returned to the ward at the end of the procedure.Postoperative day 1: on rounds, the operated eye showed decreased vision because no iol was implanted.The slit-lamp exam reveled conjunctival injection (+), diffuse corneal (stromal) edema with endothelial folds.The pupil was round, and the direct and indirect pupillary light reflexes were sluggish.No further information is available.

• 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: 23795228
• Report Number: 3012236936-2025-000313
• Device Sequence Number: 14839551
• Product Code: HQL
• UDI-Device Identifier: 05050474502086
• UDI-Public: (01)05050474502086(17)290204
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00190
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown