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	07/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the fully inserted intraocular lens (iol) was explanted from the patient's left eye (os) during a secondary surgery.The issue was first identified after implantation.No medical attention was sought.No incision enlargement, suture, or vitrectomy was required.There was no delay in procedure.Directions for use were followed.The product is not available for return.Through follow-up it was learned that the patient was very unhappy with os vision.The patient was experiencing ghosting of letters and felt that the reading vision was compromised, however the patient reported that os distance vision was fine.The patient also reported halos when driving at night time.The patient's symptoms of halos were first noted on (b)(6) 2022.A non johnson and johnson iol was implanted as replacement (different diopter of +20.5).There was no patient injury.The patient is doing great post-operatively.No further information was provided.
Additional Manufacturer Narrative
(patient weight) and (ethnicity): unknown; requested but not provided.The device is not available 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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• 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: 15897430
• Report Number: 3012236936-2022-02880
• Device Sequence Number: 17445617
• Product Code: MFK
• UDI-Device Identifier: 05050474750708
• UDI-Public: (01)05050474750708(17)241006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/01/2022

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: 10/06/2024
• Device Model Number: DFR00V
• Device Catalogue Number: DFR00VU215
• 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: 11/04/2022
• Initial Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2021
• 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: 51 YR
• Patient Sex: Female
• Patient Race: White