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

Model Number	ZCU225
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blurred Vision (2137)
Date of Event	08/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: information unknown/not provided.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), model zcu225 with 26.5 diopter (d) and 2.25 cylinder (cyl), was explanted from the patient's right eye as the vision was blurry due to not having enough cyl.The replacement iol was lens model zcu300 with 27.0 d and 3.00 cyl.The incision was enlarged to remove the iol and sutures were placed.Visual acuity pre-operative was 20/400 (pre-replacement) and visual acuity post-operative (post-replacement) was 20/50+.Three weeks later account indicated that the patient¿s vision improved from 20/70 to 20/40 without correction.No further information was provided.
Additional Manufacturer Narrative
Corrected data: in review, it was noted that the information that "there was no patient injury" was inadvertently not included in the section "b5" of the initial mdr report; therefore, it has been captured in this supplemental mdr report.Additional information: section h3: device evaluated by manufacturer: yes.Device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing records review the manufacturing records for the intraocular lens were reviewed and one non-conformance (nc) report was found as part of this manufacturing records review.This nc does not contribute to the complaint event reported.The product was manufactured and released according to specification.A search in complaint system revealed that no other complaints have been received for this production order number.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 and johnson surgical vision, inc.Has been submitted.

• 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
• Manufacturer Contact: somyata nagpal ; 1700 e st andrew place; santa ana, CA 92705 ; 7142478552
• MDR Report Key: 12739969
• Report Number: 2020664-2021-07989
• Device Sequence Number: 4920326
• Product Code: HQL
• UDI-Device Identifier: 05050474659100
• UDI-Public: (01)05050474659100(17)241122
• 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: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2024
• Device Model Number: ZCU225
• Device Catalogue Number: ZCU225U265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White