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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Halo (2227)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was initially reported patient is complaining of severe nighttime halo with an intraocular lens (iol).Surgeon planned on doing a lens exchange.Through follow-up, when the patient had the synergy iol, the patient was 20/20 uncorrected at all distances (distance, intermediate and reading).There was no residual refractive error, but the patient was not able to drive at night because of too many halos that did not make her feel safe.Therefore, the lens was explanted from the patient's right eye.There was no vitrectomy, incision enlargement, or sutures required.After an uncomplicated iol exchange with another johnson & johnson dib00 lens (different model and higher diopter), most of the patient¿s symptoms were resolved and the patient felt that she could now drive at night.No additional information was provided.
Additional Manufacturer Narrative
Ethnicity: unknown/asked but not provided.Device evaluation: the device was not returned for evaluation; therefore, product testing could not be performed, and the customer¿s reported complaint could not be verified.Manufacturing record review: the manufacturing records for the product were reviewed.The product was manufactured and released according to specification.The search in complaint history revealed one other complaint was received which was a duplicate complaint which was voided.Conclusion: as a result of the investigation there is no indication of a product quality deficiency, and the reported issue could not be confirmed.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: returned to manufacturer on: mar 8, 2022.Section h3: device evaluated by manufacturer¿ yes.Device evaluation: the complaint lens was received inside of a specimen cup.Visual inspection under magnification revealed that the lens was received cut into three pieces.No issues related to or could have contributed to visual issues were observed.Based on the return condition of the lens (cut into three pieces), no further product evaluation could be performed on the lens.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS 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: 13615977
• Report Number: 3012236936-2022-00513
• Device Sequence Number: 13999972
• Product Code: HQL
• UDI-Device Identifier: 05050474750517
• UDI-Public: (01)05050474750517(17)240909
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2022

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: 09/09/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU120
• 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: 02/02/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 02/27/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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 Sex: Female
• Patient Weight: 66 KG
• Patient Race: White