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

Model Number	ZCU225
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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 phone number: (b)(4).Device evaluation: product evaluation cannot be performed as 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 other 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 an intraocular lens (iol) was implanted in a study subject and the operative iol axis estimate right eye (od) was 114 degrees.But at 3-month study postoperative iol axis estimate od: 102 degrees.Uncorrected visual acuity od at the 3-month postoperative visit: 20/12.5.Manifest refraction: plano.Best-corrected distance visual acuity: 20/12.5.Subject reported no visual symptoms at this visit.No surgical intervention is planned at this time.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 01 degree.There is still no surgical intervention planned.The subject has completed the study.Subject: (b)(6).Visit schedule: po 3 month.Page: analyst 1 review.Study eye: od.Delta angle from base: 0.075.Subject: (b)(6).Visit schedule: po 3 month.Page: analyst 2 review.Study eye: od.Delta angle from base: 0.659.

• Brand Name: TECNIS IOL
• Common Device Name: INTRAOCULAR LENS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• MDR Report Key: 11376938
• Report Number: 9614546-2021-07076
• Device Sequence Number: 4037519
• Product Code: HQL
• UDI-Device Identifier: 05050474658950
• UDI-Public: (01)05050474658950(17)250225
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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: 02/25/2025
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U190
• 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: 01/28/2021
• Initial Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR