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

Model Number	ZCU150
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Halo (2227)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information unknown, not provided.If explanted, give date: not applicable, as the lens remains implanted.(b)(4).Device evaluation: product evaluation cannot be performed because the lens remains implanted.The complaint issue reported could not be verified and no product deficiency could be identified.Manufacturing record review: the manufacturing process record was evaluated and revealed that the product was manufactured and released according to specifications.A search revealed that no additional complaints were received from this production order.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.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 had intraocular lens (iol) rotation of approximately 13 degrees.Uncorrected visual acuity right eye (od) at the 3-month postoperative visit: 20/25.Manifest refraction od: -0.25 sphere.Best-corrected visual acuity od: 20/16.Subject reported mild halos at this visit.No surgical intervention is planned at this time.This is the final study visit for this subject; completed the study on (b)(6) 2020 it was stated that there was no patient complication and/or related injury.Outcome do not significantly interfere with activities of daily life.Current patient status is the patient has recovered.No other information was provided.
Additional Manufacturer Narrative
The complaint below 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 02 degrees.There is still no surgical intervention planned, and the subject has exited the study.Subject visit schedule, page, study eye, delta angle from base: 80729512009, po 3 month, analyst 1 review od, -1.036; 80729512009, po 3 month, analyst 2 review od, -1.071.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; gronigen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11128625
• Report Number: 9614546-2021-07004
• Device Sequence Number: 3334661
• Product Code: HQL
• UDI-Device Identifier: 05050474657816
• UDI-Public: (01)05050474657816(17)250218
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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: 02/18/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement 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: 64 YR