MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS

Model Number	ZXT375
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Visual Impairment (2138); Halo (2227); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that a symfony toric intraocular lens (iol) was implanted in the patient's right eye (od).Post-implant the patient was myopic by 1.75d, with some residual cylinder, and the patient was very unhappy due to halos.The iol was subsequently explanted and replaced with a model diu225 lens.Patient chart noted that od vision is worse.Patient sees starbursts, especially when driving at night and oncoming traffic lights are very bright.Also noted was posterior capsule opacification (pco) in od, and a yttrium aluminum garnet (yag) procedure was done.There were no post-exchange adverse events or injuries reported.No other information provided.
Additional Manufacturer Narrative
Device evaluation: product evaluation was not performed because the product has not yet been received.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that one complaint which is coded for halo vision-transient and explant related to the codes for this investigation.However, the complaint product for this one complaint was not returned therefore, the complaint problem could not be confirmed and no escalations are required.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• MDR Report Key: 11787637
• Report Number: 2648035-2021-07666
• Device Sequence Number: 4180711
• Product Code: POE
• UDI-Device Identifier: 05050474606869
• UDI-Public: (01)05050474606869(17)230728
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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: 07/28/2023
• Device Model Number: ZXT375
• Device Catalogue Number: ZXT375U145
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/07/2021
• Supplement Date Received by Manufacturer: 05/22/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR