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

Model Number	DFW225
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Flashers (1864)
Date of Event	01/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device was not returned 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.Attempts have been made to obtain additional information regarding the event; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that after the intraocular lens (iol) was implanted the patient experienced significant positive dysphotopsia.Lots of distorted vision or bright lights even in daytime causing weird reflections in their vision.The patient's range of vision is 20/30 uncorrected distance visual acuity (ucvda), 20/10 uncorrected intermediate visual acuity (uciva), 2020 uncorrected binocular visual acuity (ucnva) with mrx +0.50 - 0.75 x 037 and 20/20 corrected distance visual acuity (cdva).The patient also feels peripheral vision is somewhat restricted.The doctor is awaiting a time to dilate patient and verify proper toric alignment and is giving the patient time to neuroadapt.The doctor has also given patient a sample of a miotic drop to see if it helps with the dysphotopsia.Additionally, it was learned that the patient is having difficulty driving.The doctor reported that the lens rotated six degrees.The iol remains implanted in the left eye, but indicated that the doctor will probably plan an iol exchange.Through additional follow-up, it was learned that the iol was exchanged in the left eye.Another johnson & johnson iol was implanted as a replacement (dfw150 25.0 diopter).There was no patient injury, but enlargement of temporal wound was required and planned.It was indicated that the patient is still unhappy with the lens and has a lot of dysphotopsia.No further information was provided.

• 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: 14440567
• Report Number: 3012236936-2022-01309
• Device Sequence Number: 12019240
• Product Code: MFK
• UDI-Device Identifier: 05050474751941
• UDI-Public: (01)05050474751941(17)240502
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/18/2022

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: 05/02/2024
• Device Model Number: DFW225
• Device Catalogue Number: DFW225U245
• 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: 04/25/2022
• Initial Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2021
• 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: 47 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White