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

Model Number	AR40E
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable, as lens remains implanted.Telephone number, (b)(6).The intraocular lens (iol) was not returned for evaluation as the lens remains implanted; 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.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that a sensar ar40e intraocular lens (iol) with markings/scratches was implanted in patient's eye.There was no delay in procedure and no vitrectomy required.The lens remains implanted in the eye and no impact on daily activities of the patient reported.There was no replacement.The customer indicated that they did not inspect the lens prior to loading it in the cartridge.No patient injury reported.The patient outcome was not provided.No further information provided.This emdr report is for the ar40e intraocular lens.A separate report will be provided for the intraocular emeraldc30 cartridge.

• 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: 15214874
• Report Number: 3012236936-2022-02122
• Device Sequence Number: 12241015
• Product Code: HQL
• UDI-Device Identifier: 05050474502192
• UDI-Public: (01)05050474502192(17)260910
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

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 Expiration Date: 09/10/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00245
• 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: 07/18/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2021
• 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: EMERALD CARTRIDGE LOT CJ33939
• Patient Sex: Unknown