MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS IOL; INTRAOCULAR LENS

Model Number ZCB00

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

Patient Problems Blurred Vision (2137); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

Additional information: patient age, weight, and ethnicity: unknown as information was not provided.Date of event: unknown as information was not provided.Date explanted: not applicable as the iol remains implanted in the patient's ocular sinister (left eye).It was indicated that the iol is not being returned for evaluation as it remains implanted in the patient¿s os therefore, a failure analysis of the complaint device cannot be completed.A review of the device/lot history record and historical data analysis for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch report will be filed.(b)(4).The device was manufactured at the (b)(4) site, which has been closed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported the intraocular lens (iol) was implanted in the patient's ocular sinister (left eye).Patient reports complaints of blurry and cloudy vision and sharp pain.Yttrium aluminum garnet (yag) procedure was performed.Patient has not been able to seek a second opinion regarding her reported issues due to health issues resulting from stroke.No further information is available.

Manufacturer Narrative

Corrected data: in further review of the file, it was noted that section g3 date received by manufacture (08-jun-2021) reported in the initial mdr was incorrect.The correct date is 14-jun-2021 as follow-up information regarding yag procedure was received on 14-jun-2021.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: TECNIS IOL
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 12132195
• MDR Text Key: 260476745
• Report Number: 2020664-2021-07050
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531758
• UDI-Public: (01)05050474531758(17)220319
• Combination Product (y/n): N
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention