MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS IOL; INTRAOCULAR LENS

Model Number	ZCU150
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight and ethnicity: unknown/ not provided.If explanted, give date: not applicable, as lens remains implanted.Manufacturer telephone number: (b)(4).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 study patient was implanted an intraocular lens (iol).Iol was implanted at 61 degrees on op day.At day 1, it was noted that the iol was 058 degrees.At week 1, iol was noted to be at 047 degrees.It was stated that the outcome does not significantly interfere with the patient¿s daily life.Nevertheless, additional information was received that at 1-week postoperative iol axis was estimated to be right eye (od) at 047 degrees.The uncorrected visual acuity od at the 1-week postoperative (po) visit: 20/25.Manifest refraction od: +0.75 -0.50 x 042.Best-corrected visual acuity od: 20/25.Subject reported no visual symptom complaints this visit.There was no surgical intervention planned at this time.It was learned in further follow-up that the complaint was based upon a subjective estimate made by the investigator from a slit-lamp measurement.For this study, clinical has also been doing independent analysis of the iol photos taken at each visit.These are objective measurements of the actual iol axis.Based on this objective measurement, the actual amount of iol rotation for the subject below is less than 03 degrees.There is still no surgical intervention planned.The subject has one more study visit left to complete (3-month study visit).The complaint was based upon a subjective estimate made by the investigator from a slit-lamp measurement.For this study, we have also been doing independent analysis of the iol photos taken at each visit.These are objective measurements of the actual iol axis.Based on this objective measurement, the actual amount of iol rotation for the subject below is less than 03 degrees.The subject has one more study visit left to complete (3-month study visit).Subject: (b)(6).Visit schedule: po 1 week - first eye.Page: analyst 1 review.Study eye: od.Delta angle from base: 1.638.Subject (b)(6).Visit schedule: po 1 week - first eye.Page: analyst 2 review.Study eye: od.Delta angle from base: -2.136.No other information was provided.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11290038
• Report Number: 9614546-2021-07045
• Device Sequence Number: 17004341
• Product Code: HQL
• UDI-Device Identifier: 05050474657786
• UDI-Public: (01)05050474657786(17)241114
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/05/2021

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: 11/14/2024
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U195
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR