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

Model Number	ZXT225
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown, not provided.If explanted; give date: n/a (not applicable).Lens remains implanted.Manufacturer phone number: (b)(4).The intraocular lens (iol) is not returning for evaluation as it remains implanted; therefore, failure analysis of the complaint device cannot be completed.A review of the device 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
A report was received for a study patient who was implanted with a tecnis symfony intraocular lens (iol).The site has noted an axis misalignment on (b)(6) 2021, in the subject's right eye (od).Pre-operative best corrected distance visual acuity (bcdva): 20/30 right eye.Iol axis placement: 90 at time of surgery.At one-month post-op visit on (b)(6) 2021; uncorrected distance visual acuity (ucdva) 20/30, bcdva 20/25 right eye.Iol axis placement 67 (post-op axis).No intervention planned at this time, the subject is satisfied with their vision currently.No additional information provided.

• 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: 11347095
• Report Number: 9614546-2021-07056
• Device Sequence Number: 19850992
• Product Code: POE
• UDI-Device Identifier: 05050474605640
• UDI-Public: (01)05050474605640(17)211125
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2021
• Device Model Number: ZXT225
• Device Catalogue Number: ZXT225U125
• 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: 01/21/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 73 YR