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 Codes	Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Eye Pain (4467)
Date of Event	02/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight and ethnicity: unknown/not provided.The device was not returned for evaluation as it was discarded; 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.(b)(4).Attempts have been made to obtain the missing information.However, to date it has not been received.All pertinent information available to johnson & johnson surgical vision, inc., has been submitted.
Event or Problem Description
Health care provider reported they explanted johnson & johnson lens from the patient's right eye, because they were experiencing subjective visual disturbances: halos around light, glare, and eyes felt tired, hurt, achy, and pain.Patient is very sensitive to light.Their distance and near vision is blurry.The issues were observed during a post-operative (op) exam.The explanted iol will not be returned as it was discarded by the customer.The patient¿s current status is unknown.This patient had bilateral explants.This report is for the right eye mfr report number 3012236936-2022-01253.The left eye is reported via mfr report number 3012236936-2022-01254.

• 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: 14459759
• Report Number: 3012236936-2022-01253
• Device Sequence Number: 17314967
• Product Code: HQL
• UDI-Device Identifier: 05050474750685
• UDI-Public: (01)05050474750685(17)240813
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

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: 08/13/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU205
• 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: 05/10/2022
• Initial Report FDA Received Date: 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2021
• 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