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	Visual Disturbances (2140)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the intraocular lens (iol) was fully inserted in the patient's left eye, the patient experienced "other" visual disturbances which was observed during a post-operative examination.The symptoms persisted for the amount of time between surgeries.The iol was explanted.The incision was enlarged.No sutures or vitrectomy was required.No medication was prescribed.Directions for use were followed.No further information is available.
Additional Manufacturer Narrative
Date of event: unknown/not provided.But the best estimate date is between (b)(6) 2022 and (b)(6) 2022.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.
Additional Manufacturer Narrative
Additional information: section d9: device available for evaluation? yes , section d9: date returned to manufacturer: feb 28, 2023, section h3: evaluated by manufacturer: yes.Device evaluation: the product was returned to the manufacturing site for evaluation.The suspect iol was cleaned and visual inspection under magnification found scratches on the lens optic.No issues that could cause or contribute to the complaint event were observed.Based on the returned condition of the lens, no further evaluation was performed.The complaint issues were not confirmed.The other observed issue found during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation there is no indication of a product quality deficiency.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: 15577494
• Report Number: 3012236936-2022-02557
• Device Sequence Number: 12439005
• Product Code: HQL
• UDI-Device Identifier: 05050474501935
• UDI-Public: (01)05050474501935(17)260211
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 04/05/2023

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: 02/11/2026
• Device Model Number: AR40E
• Device Catalogue Number: AR40E00110
• 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: 09/14/2022
• Supplement Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 154 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White