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	03/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section a2, a3, a4 and a5: per regulation eu (b)(4) (general data protection regulation), patient identifiers were not collected or recorded and therefore are not available.Section d4: catalog number: partial number indicated, as the serial number was not provided.Section d4: serial number: unknown, information not provided.Section d4: expiration date: unknown, as the serial number was not provided.Section d4: udi number: unknown, as the serial number was not provided.Section d6a - implant date: not applicable, as the lens was removed during the same procedure.Section d6b - explant date: not applicable, as the lens was removed during the same procedure.Section e1 - telephone number: (b)(6).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 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 h4: device manufacture date: unknown, as the serial number was not provided.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the intraocular lens (iol) was defective coming out of the inserter.The issue was first identified during implantation.The lens was inserted and removed during the same procedure.It was reported that the patient has fully recovered.The material is not available for investigation.No further details were provided.
Additional Manufacturer Narrative
Additional information and corrected data: this supplemental filing is to update the following fields per new information received: section b5 - describe event or problem: the intraocular lens (iol) was damaged during the loading process.The surgery was successfully completed with the backup lens, serial number (b)(6) (same model and diopter as the original iol).Section d4 - model number: ar40e section d4 - catalog number: ar40e00170 section d4 - serial number: (b)(6).Section d4 - expiration date: 28-feb-2029 section d4 - udi number: (b)(4).Section h4 - device manufacture date: 29-feb-2024 all pertinent information available to johnson and 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: 21704030
• Report Number: 3012236936-2025-000070
• Device Sequence Number: 9941842
• Product Code: HQL
• UDI-Device Identifier: 05050474502048
• UDI-Public: (01)05050474502048(17)290228
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: 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: 03/03/2025
• Supplement Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/29/2024
• 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