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

Model Number	ZCU300
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	01/22/2021
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) had rotation of approximately 10 degrees.The study patient's pre-op best corrected distance visual acuity (bcdva) left eye (os) was 20/40.Uncorrected visual acuity os at the 1-day postoperative visit: 20/40.Subject reported no visual symptom complaints in this visit.Outcome doesn't significantly interfere with the patient's regular activities.At the 1-week study visit uncorrected visual acuity (va) os was 20/25, manifest refraction os was +0.50 -0.50 x076, best-corrected va os was 20/20.Patient¿s only visual symptom complaint was ¿color distortion¿.Subject to return for the 3-month study visit.No surgical intervention is planned at this time.It was learned that the complaint study was based upon a subjective estimate made by the investigator from a slit-lamp measurement.For this study, 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 is continuing in the study.There is no further information provided.

• 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: 11363910
• Report Number: 9614546-2021-07051
• Device Sequence Number: 19094240
• Product Code: HQL
• UDI-Device Identifier: 05050474660250
• UDI-Public: (01)05050474660250(17)240919
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 02/22/2021

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: 09/19/2024
• Device Model Number: ZCU300
• Device Catalogue Number: ZCU300U250
• 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: 01/26/2021
• Initial Report FDA Received Date: 02/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR