MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS TORIC II 1-PIECE; MONFOCAL

Model Number ZCU150

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 08/24/2020

Event Type  Injury  

Manufacturer Narrative

The intraocular lens (iol) is not returning for evaluation as it is 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.(b)(4).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that an intraocular lens (iol) was explanted from the patient's operative eye.Through follow-up, it was learned the iol had dislocated in the patient's right eye.The incision was enlarged and a suture was required when the lens was explanted.Another johnson & johnson lens (different model and lower diopter) was successfully implanted as a replacement.The suspect lens was dropped and could not be found.The patient discharged in good condition.No additional information was provided.

• Brand Name: TECNIS TORIC II 1-PIECE
• Type of Device: MONFOCAL
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• Manufacturer (Section G): JOHNSON & JOHNSON SURGICAL VISION, INC.; van swietenlaan 5; groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478200
• MDR Report Key: 10564409
• MDR Text Key: 207900839
• Report Number: 9614546-2020-00422
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474657533
• UDI-Public: (01)05050474657533(17)250709
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCU150
• Device Catalogue Number: ZCU150U070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR