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

Model Number	DFR00V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product testing could not be performed as the product was not returned.The reported event could not be verified, and no product deficiency could be identified.The manufacturing records for the product were reviewed.The product was manufactured and released according to specifications.A search revealed that no other complaints were received for this production order.Based on the investigation, no product deficiency was identified.Attempts have been made to obtain missing information; however, the account did not provide the information.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
It was reported that an intraocular lens (iol) was explanted from the patient's right eye due to them experiencing dysphotopsia.Chief complaint is blurry vision, halos and glare.The complaint of blurry vision was at one week post-operation.The explanted iol will not be returned as it was discarded by the customer.The replacement lens is a non j&j iol diopter 21.5.Reportedly, there was no capsule tear and the patient is doing well, happy with vision.

• Brand Name: TECNIS IOL
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• 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: 15658708
• Report Number: 3012236936-2022-02528
• Device Sequence Number: 12191449
• Product Code: MFK
• UDI-Device Identifier: 05050474750715
• UDI-Public: (01)05050474750715(17)241018
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2022

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: 10/18/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU220
• 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: 09/29/2022
• Initial Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 70 KG
• Patient Race: White