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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The surgery center reported back haptic all twisted up coming out with a monofocal intraocular lens (iol).They also reported loading error.There was patient contact and the lens was placed in the eye.The issue was noted after implantation of the lens.No further information was provided.
Additional Manufacturer Narrative
Section d6a: if implanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Section d6b: if explanted; give date: n/a (not applicable).The intraocular lens was inserted and removed during the same procedure.Section h3: the intraocular lens (iol) was not returned for evaluation.Therefore, a failure analysis of the complaint device could not be completed.A review of records related to the device including labeling and complaint trending will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation: yes.Section d9: returned to manufacturer on: jun 10, 2025.Section h3: device evaluated by manufacturer: yes.Device evaluation: the original daisy wheel was received inside the original folding carton.The patient stickers, implant notification card, and patient implant notification card were also received.No lens was received.Product evaluation was not performed because the product has not been received.Based on the complaint investigation results, the product was released within specifications.Conclusion: as a result of the investigation, no malfunction or product deficiency was identified.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: 22189339
• Report Number: 3012236936-2025-000164
• Device Sequence Number: 8691153
• Product Code: HQL
• UDI-Device Identifier: 05050474502208
• UDI-Public: (01)05050474502208(17)291023
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: AR40E00250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/19/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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
• Patient Sex: Unknown