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

Model Number	AR40E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.If implanted, give date: unknown/not provided.The intraocular lens (iol) 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 the missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc has been submitted.
Event or Problem Description
It was reported that patient presented with blurry vision secondary to residual myopia (-7.00) post sensar ar40e model intraocular lens (iol) implantation.Account indicated that patient with 20/20 pre-operative visual acuity.The iol was explanted and exchanged in a secondary procedure on (b)(6) 2021.No further information provided.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes.Section d9: returned to manufacturer: yes.Returned to manufacturer on jan 29, 2022.Section h3.Device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection revealed viscoelastic residue on the optic body and haptics and that the lens was received cut in half, which is consistent with a lens that was handled during explant.Based on the return condition of the lens, no further product evaluation could be performed.The complaint issue could not be confirmed, and no product deficiency could be 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: 13287373
• Report Number: 3012236936-2022-00161
• Device Sequence Number: 19903618
• Product Code: HQL
• UDI-Device Identifier: 05050474501959
• UDI-Public: (01)05050474501959(17)240617
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/17/2024
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00125
• 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: 12/23/2021
• Supplement Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2019
• 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: Female