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

Model Number	ZXT150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Flashers (1864); Halo (2227)
Date of Event	06/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unknown/ not provided.If explanted, give date: not applicable, as lens remains implanted.The device is not returning for evaluation as it remains implanted; therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and complaint trending 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.
Event or Problem Description
It was reported that a clinical subject returned for 6 month visit.Uncorrected distance visual acuity (ucdva) 20/25 right eye (od), 20/20 left eye (os); best corrected distance visual acuity (bcdva) 20/20 both eyes (ou).On the questionnaire, the subject noted as very bothered by starbursts while driving at night.No plans for surgical intervention at this time.Follow-up confirmed that the subject stated the starbursts in particular are debilitating.He described them as severe and stated that he is unable to drive at night due to the starbursts.The doctor discussed lens exchange and yttrium aluminum garnet (yag) with patient to try to relieve these symptoms.Patient is scheduled for a yag evaluation on (b)(6) 2021 to determine if this is the option he will proceed with.Unscheduled visit noted ucdva 20/25 ou; bcdva 20/15 od, 20/20 os.On the questionnaire, the subject complained being very bothered by halos while driving at night; very bothered by starbursts while driving at night and very bothered by glare while driving and watching tv.No plans for intervention at this time.Month 1 visit noted visual acuity ucdva 20/20 ou and bcdva 20/15 ou.The following complaint was reported: very bothered by halos ¿ drive at night; and very bothered by starbursts- night driving.No treatment planned.Preoperative visual acuity: ucdva 20/200 ou; bcva 20/25 od, 20/20 os.No other information was provided.This report captures event on suspect iol for os.A separate report will be submitted for suspect od.

• 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: 12586604
• Report Number: 2020664-2021-07652
• Device Sequence Number: 3787925
• Product Code: POE
• UDI-Device Identifier: 05050474605176
• UDI-Public: (01)05050474605176(17)231101
• 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: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: 11/01/2023
• Device Model Number: ZXT150
• Device Catalogue Number: ZXT150U185
• 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: 09/08/2021
• Initial Report FDA Received Date: 10/06/2021
• 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: Other
• Patient Age: 67 YR