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

Model Number	AR40E
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Vitreous Hemorrhage (2143); Capsular Bag Tear (2639); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section a3a, a3b, a4, a5 and a6: unknown, information was requested but not provided.Section d6b: if explanted; give date: not applicable as the device remains implanted.Section e1 first name: unknown/not provided.Section h3: the device was not returned for evaluation as the lens remains implanted; 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 this review, if there is any further relevant information, a supplemental medwatch will be filed.Section h6: health effect - clinical code: 4581 - this code was used for the reported device decentered or dislocated or tilted subluxated.Attempts were made to obtain additional information regarding the event; however, the information was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that during a surgical procedure conducted on (b)(6), 2026, the front haptic of the original lens was noted to be bent during preparation and insertion, while the back haptic had not yet entered the eye.The lens was partially delivered and subsequently removed from the patient's eye.A replacement lens of the same model and diopter was loaded and inserted using an unspecified cartridge.During the implantation of the replacement lens, a capsule tear occurred, requiring an anterior vitrectomy.Two hours after the surgery, the implant was observed to be dislocated, and the patient showed signs of a potential vitreous hemorrhage.A follow-up examination one week later revealed the implant positioned near the bottom of the vitreous cavity, leading to the scheduling of a second surgery with a retina physician on (b)(6), 2026, to retrieve and/or replace the implant.The surgeon reported encountering resistance and needing additional force during the insertion of the implants, as well as employing extra surgical maneuvers beyond standard practice.No further information was provided.This report is for the replacement lens.The issue with the original lens does not meet the reportability criteria.

• 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: 24918703
• Report Number: 3012236936-2026-000100
• Device Sequence Number: 10420493
• Product Code: HQL
• UDI-Device Identifier: 05050474502123
• UDI-Public: (01)05050474502123(17)301110
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 04/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00210
• 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: 04/16/2026
• Initial Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL/LOT #: UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown