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	Eye Injury (1845)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the non-preloaded intraocular lens (iol) was wasted, vitrectomy was performed.There was patient contact.It was noted that the lens was not removed in a secondary procedure.The lens is not available to be returned.No further information was provided.Through follow up, it was learned that wasted meant the surgeon noted a haptic broke while in the injector.There was a loading issue.It was unknown if there was patient contact or the extent of patient contact.All that was provided was lens was not inserted.It was unknown if the vitrectomy was performed prior to patient contact or after patient contact.It was unknown if there was patient injury.A different lens was inserted.The lens is not available for return.No other information is available.
Additional Manufacturer Narrative
Section a2, a3a, a3b, a4, a5, a6: unknown/asked but unavailable (asku).Section d6a: if implanted; give date: unknown/not provided.Section d6b: if explanted; give date: unknown/not provided.Section e1: first/given name: unknown/not provided.Only initial of first name was provided.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.An attempt has been made to obtain missing information; however, the account did not have the information.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: 21233825
• Report Number: 3012236936-2025-000020
• Device Sequence Number: 8603240
• Product Code: HQL
• UDI-Device Identifier: 05050474514157
• UDI-Public: (01)05050474514157(17)280307
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2025

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: AR40E00115
• 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: 01/03/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2023
• 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