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	Flashers (1864); Vitreous Floaters (1866); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Insufficient Information (4580)
Date of Event	06/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight & ethnicity: unknown, not provided.Date of event: exact onset date of symptoms, only that patient noticed them one week post surgery.Therefore, (b)(6) 2018 is provided as a best estimate.Manufacturer telephone number: (b)(6).Other: the device is not returning for evaluation as it was discarded; 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 patient noticed symptoms one week post-implant of a model zxr00 intraocular lens (iol) in the right eye (od).Symptoms reported were starbursts, haze, and blurry vision.The lens was subsequently explanted due to diffractive lens intolerance, mildly myopic, and some astigmatism with significant floaters.A pars plana vitrectomy was performed.At explant there was no incision enlargement, and no injury reported.The explanted lens was discarded and the replacement lens is a non-johnson & johnson iol.Post-exchange the patient's vision is good and really clear, starbursts have resolved.No other information was provided.
Additional Manufacturer Narrative
Upon further review, it was noted that in the initial mdr section h-6 health effect - clinical codes: 1866 - vitreous floaters, 2138 - visual impairment (unexpected post-op refraction), and 4580 (diffractive lens intolerance) were inadvertently not captured.Therefore, this supplemental filing is to correct the codes that were was not originally captured.Section b-5 describe event or problem: it was also initially reported diffractive lens intolerance, mildly myopic with some astigmatism, and significant vitreous floaters also contributed to iol explant.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was also initially reported diffractive lens intolerance, mildly myopic with some astigmatism, and significant vitreous floaters also contributed to iol explant.

• 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: 11873858
• Report Number: 9614546-2021-07173
• Device Sequence Number: 804821
• Product Code: POE
• UDI-Device Identifier: 05050474579132
• UDI-Public: (01)05050474579132(17)230316
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 03/16/2023
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 05/24/2021
• Supplement Report FDA Received Date: 08/17/2021
• 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: 74 YR