MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. TECNIS IOL; INTRAOCULAR LENS

Model Number ZCB00V

Device Problem Scratched Material (3020)

Patient Problem Blurred Vision (2137)

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown, not provided.Best estimate of date of event is between (b)(6) 2022 and (b)(6) 2022.Telephone number: (b)(6).This report is being filed on an international device; tecnis 1-pc optiblue mono 6.0mm 28.0d 1-piece iol, model zcb00v that has a similar device, tecnis simplicity preloaded 1-piece iol model zcb00 which is distributed in the unites states under pma p980040.Attempts have been made to obtain missing information.However, to date, no response has been received.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that the lens will be explanted from the patient's left eye due to a lens surface defect.Through follow-up we learned that the lens has been explanted and that the patient could not see very well with the initially implanted lens.Vision pre-op :0.80, post-op 1.00.No further details were provided.

Manufacturer Narrative

Additional information: section d9 - device available for evaluation? yes.Section d9 - date returned to manufacturer: february 23, 2023.Section h3 - device evaluated by manufacturer? yes.Device evaluation: the product was returned to the manufacturing site for evaluation.Visual inspection under magnification revealed that the lens was cut in half.The lens was cleaned and further inspected under magnification and no cosmetic issues were observed.No other issues were observed with the suspect lens.The complaint issues of cosmetic issues and blurry vision were not identified during product evaluation.The other observed issues during the product evaluation could not be confirmed to be related to a manufacturing or design issue.Therefore, there is no indication of a product deficiency or product malfunction.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15965471
• MDR Text Key: 308375833
• Report Number: 3012236936-2022-02950
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474546905
• UDI-Public: (01)05050474546905(17)260914
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCB00V
• Device Catalogue Number: ZCB00V0280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female