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

Model Number	ZXR00
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dry Eye(s) (1814); Blurred Vision (2137)
Date of Event	11/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable.The lens remains implanted.The intraocular lens (iol) 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 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.
Event or Problem Description
It was initially reported that a patient with poor visual acuity outcome with an intraocular lens (iol) will have an iol exchange.Through follow-up, it was learned the patient had a refractive clear lens exchange as the patient did not have cataracts pre-operative.Visual acuity (va) pre-op: uncorrected visual acuity (ucva): 20/300 j1.J10 20/20 is the best the patient has ever measured post-operative.The distance visual acuity (va) is great, but patient has poor intermediate/near va or blurry near vision post-op.A yttrium aluminum garnet (yag) laser was performed on (b)(6) 2020 and the dry eye was treated.A secondary surgery/medical intervention is not required.There was no vitrectomy, incision enlargement, or sutures required.Nor is an explant planned.The lens remains implanted at this time.No additional information was provided.
Additional Manufacturer Narrative
Correction: upon further review, it was noted that the reported event has been previously reported under mfr report number 9614546-2020-00544.Therefore, this file is no longer considered reportable.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 MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11661773
• Report Number: 9614546-2021-07128
• Device Sequence Number: 3097260
• Product Code: POE
• UDI-Device Identifier: 05050474579040
• UDI-Public: (01)05050474579040(17)230702
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 05/20/2021

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: 07/02/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0175
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/20/2021
• 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: 46 YR