MAUDE Adverse Event Report: AMO MANUFACTURING NETHERLANDS TECNIS SYNERGY TORIC II; LENS, MULTIFOCAL INTRAOCULAR

Model Number ZFW100

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

Patient Problems Visual Disturbances (2140); Halo (2227)

Event Date 06/08/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter telephone number: (b)(6).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.An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that a toric intraocular lens (iol) was explanted due to patient having glare and halos.There are no issues regarding visual acuity.Vision pre-operative: far: 0.6 near: jaeger 5 (decimal).Vision post-operative: far: 1.0.Daily activity was affected especially at night time.The iol was exchanged with a mono-focal iol.No incision enlargement, vitrectomy, and sutures required.No further information was provided.

• Brand Name: TECNIS SYNERGY TORIC II
• Type of Device: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): AMO MANUFACTURING NETHERLANDS; van swietenlaan 5; groningen, groningen 9728 NX; NL 9728 NX
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15891526
• MDR Text Key: 304589953
• Report Number: 3012236936-2022-02977
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474715301
• UDI-Public: (01)05050474715301(17)251118
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZFW100
• Device Catalogue Number: ZFW100I245
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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