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

Model Number ZCT150

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Zonular Dehiscence (2698); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

Weight and ethnicity: unknown, information not provided.If implanted, give date: not applicable, as lens was removed/replaced in the initial surgery.If explanted, give date: not applicable, as lens was removed/replaced in the initial surgery.Telephone number: (b)(4).The device was not returned for analysis as the lens was discarded.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.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a zct150 model intraocular lens(iol) was implanted and then cut in half to remove due to a zonular defect.Customer does not have the lens since they cut it out.There was no patient injury and no medical/ surgical interventions such as sutures or vitrectomy was performed but incision was enlarged.Procedure was completed successfully using a non johnson and johnson surgical vision lens.Patient was doing well doing the post-op.No further information available.

• Brand Name: TECNIS IOL
• Type of Device: LENS, INTRAOCULAR, TORIC OPTICS
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; van swietenlaan 5; groningen, groningen 9728 -NX ; NL 9728 NX
• MDR Report Key: 11845065
• MDR Text Key: 251289355
• Report Number: 9614546-2021-07155
• Device Sequence Number: 1
• Product Code: MJP
• UDI-Device Identifier: 05050474552098
• UDI-Public: (01)05050474552098(17)221012
• 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 faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2018
• 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
• Treatment: 1VIPR30 ,LOT NUMBER: CH16236
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR