MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: unknown, not provided.Best estimate of date of event is between sept.25, 2019 and jun.29, 2020.The 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.Health effect clinical code: 4581(eye anatomy issue : pre-existing disease).An attempt has been made to obtain missing information; however, no definitive response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a patient who had bilateral lens implants, after the surgery experienced pain in eye which felt like wood in their eyes.Dryness with blurry scaly feeling.For months patient unable to drive at night because of glare in eyesight and decreased eyesight.Diagnosed with significant posterior capsular opacification (pco), yag done in left eye (os).Right eye (od) implant was explanted due to mechanical complications of the intraocular lens (iol).Further review however noted from the patient chart provided that event started as bilateral cataract extraction.Os was implanted first.However, at one month post-implant of os, lens for right eye (od) was also implanted due to existing cataract, dry eye syndrome and open angle glaucoma.Vision was good for both eyes (ou), fairly stable.Visual issues (including burry, glare, halo and decrease in vision), this time also including starburst when driving at night occurred in ou.After issues of not getting better, patient was referred to another doctor to explant od.Od was explanted as patient prefers distance with monofocal.Original lens was replaced with a zcu300 lens, same diopter size as original lens.At one day post-explant od, patient vision was good, improving.But almost a month post-explant patient started having trouble again reading and watching tv at 10 ft.Post v/a (visual acuity) 20/20.A month later, blurred vision, aggravating problem.But describes vision as fair.The following month the patient wanted lasik done, hence they proceeded with lasik.At 5 wks.Post-lasik, vision good, stable, no other complaints.No other information was provided.This report is for the right eye.A separate report will be submitted for the left eye of the patient.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16570127
• Report Number: 3012236936-2023-00588
• Device Sequence Number: 17676832
• Product Code: POE
• UDI-Device Identifier: 05050474606425
• UDI-Public: (01)05050474606425(17)230628
• 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: 2019
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

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: 06/28/2023
• Device Model Number: ZXT300
• Device Catalogue Number: ZXT300U220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2018
• 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: 65 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White