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

Model Number	ZXR00
Health Effect - Clinical Codes	Macular Edema (1822); Blurred Vision (2137); Visual Disturbances (2140); Eye Pain (4467)
Date of Event	11/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown as information was not provided.If explanted, give date: not applicable, as the iol remains implanted in the patient's od.Phone number: (b)(6).It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s od therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
Event or Problem Description
The intraocular lens (iol) was implanted in the patient's ocular dexter (right eye).Patient reported, shortly after the surgery, complaints of od being uncomfortable-irritating, sore, feels like she wore contact lenses too long.She uses artificial tears when needed.Patient reported uncomfortable feeling as same or better now.Patient can see the outline of the iol, which was noticed right after surgery.Near vision is poor and has difficulty working on the computer and reading.Results are not as expected.Distance vision is good, approximately 20/25.Od had cloudiness which was corrected by laser, cloudiness is now better.Through follow-up, additional information was received stating od is especially blurry and possible swelling of the retina.No further information is available.This report captures the iol in the patient's ocular dexter (right eye).A separate report will be filed for the patient's ocular sinister (left eye).

• Brand Name: TECNIS IOL
• Common Device Name: EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11335955
• Report Number: 9614546-2021-07067
• Device Sequence Number: 11649049
• Product Code: POE
• UDI-Device Identifier: 05050474591639
• UDI-Public: (01)05050474591639(17)220516
• 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: 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): 02/16/2021

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: 05/16/2022
• Device Model Number: ZXR00
• Device Catalogue Number: ZXR00U0095
• 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: 01/20/2021
• Initial Report FDA Received Date: 02/16/2021
• 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