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

Model Number ZCB00

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: other (81): the device was not returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts were made to obtain the missing information; however, 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 there was a deployment issue with the intraocular lens (iol).The iol was not inserted and the patient was unharmed.A sulcus iol was used.No additional information was provided.

Manufacturer Narrative

Corrected data: upon further review it was noted that event of delivery issue as submitted in the initial report is not reportable since there was no additional surgical maneuvers done, which is a criteria to make the event reportable.Therefore, this complaint is no longer considered a reportable event.Additional information: section d9.Device available for evaluation? yes.Returned to manufacturer on: dec.9, 2022.Section h3.Device evaluated manufacturer? yes.Device evaluation: visual inspection under magnification revealed that the lens was received coated in viscoelastic material.The lens was cleaned and inspected under magnification and scratches were observed on the optics and edge of the lens.No issues that could cause or contribute to the complaint issue were observed.The complaint issue "delivery issue" was 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.Conclusion: as a result of the investigation, there is no indication of a product deficiency or product malfunction.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.No further information will be provided under this manufacturer report number 3012236936-2022-02570.

• 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: 15601906
• MDR Text Key: 306435412
• Report Number: 3012236936-2022-02570
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531666
• UDI-Public: (01)05050474531666(17)250907
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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