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

Model Number	ZCU150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); Visual Impairment (2138)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event: the exact date of event is unknown, not provided, but the best estimate date is (b)(6) 2021.Phone number: (b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the device was discarded by the customer).The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records for the device were reviewed.The product was manufactured and released according to specifications.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.An attempt has been made to obtain the missing information; however, to date, the information has not been received.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 explanted from a patient¿s right eye in a secondary surgical procedure due to the power miss and blurry vision.There was no surgical intervention such as vitrectomy, incision enlargement or sutures required.A replacement lens of the same model, but a different diopter (27.0) was used.The patient outcome was reported to be good and no injury was reported.The explanted lens was discarded by the account.No further information was 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: 11600789
• Report Number: 9614546-2021-07114
• Device Sequence Number: 14504558
• Product Code: HQL
• UDI-Device Identifier: 05050474657878
• UDI-Public: (01)05050474657878(17)251106
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

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: 11/06/2025
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U240
• 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: 03/03/2021
• Initial Report FDA Received Date: 04/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR