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

Model Number	AR40E
Medical Device Problem Codes	Break (1069); Failure to Fold (1255); Use of Device Problem (1670)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The surgeon had to remove the ar40e model intraocular lens (iol) during the initial procedure.It was reported that the back haptic was most likely not swept to the side due to the technician's lack of experience with loading this particular lens.It was also reported the trailing haptic was kinked.The iol was not fully inserted in the patient¿s ocular sinister (left eye) and the lens was cut out.The incision was enlarged, unplanned sutures were needed, and an unplanned vitrectomy was performed.Sutures were used as a prophylactic measure.There was no serious patient injury.Patient prognosis post-procedure was reported as aphakia.The doctor anticipates the patient will do well once the secondary lens is placed.The suspect iol is not available for return as it was not saved.No further information is available.
Additional Manufacturer Narrative
Additional information: section d-6a date implanted: not applicable as the iol was not implanted.Section d-6b date explanted: not applicable as the iol was not implanted; therefore, not explanted.Section h-3 device evaluated by manufacturer: the complaint device was not returned for evaluation as it was not saved.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 the review, if there is any further relevant information a supplemental medwatch report will be filed.Section h-6 health effect - impact code: 4625 - incision enlargement, sutures, 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: 21983038
• Report Number: 3012236936-2025-000131
• Device Sequence Number: 4311674
• Product Code: HQL
• UDI-Device Identifier: 05050474502048
• UDI-Public: (01)05050474502048(17)290702
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: AR40E00170
• 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: 04/16/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2024
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian