MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. TECNIS; TORIC IOLS

Model Number ZCT525

Device Problem Unintended Movement (3026)

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Serial number: unknown/not provided.Catalog#: the complete catalog number is unknown, as product serial number was not provided.Expiration date: unknown as product serial number was not provided.Udi number: udi # is unknown as product serial number was not provided.If explanted; give date: not applicable, lens remains implanted phone number: (b)(6).Device manufacture date: unknown as product serial number was not provided.(b)(4).Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record evaluation: manufacturing record review cannot be performed since the serial number is unknown.A search of complaints related to serial number cannot be performed since the serial number is unknown.Conclusion: no sample was returned and the serial number is unknown an investigation could not be performed, and no malfunction is confirmed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that post-implant of an intraocular lens (iol) the patient's visual acuity dropped to 6/21 on pod6 (post-op day 6).Left eye: target axis at 4 degree.Pod1 (post-op day 1) unva (uncorrected near visual acuity) 6/12.The doctor saw the patient on pod6 at the hospital and found out that the lens had rotated more than 20 degree anticlockwise from intended axis which resulted in drop of visual acuity, poor vision within a week post operation.It was indicated that the doctor used miostat intraoperative solution for the patient.The lens was rotated back to target axis in a secondary surgical procedure.The lens remains implanted and there is no plan to explant the iol.There was no incision enlargement or vitrectomy performed and no sutures were required.At the patient's most recent exam, the patient was seeing 6/6.No further information was provided.

• Brand Name: TECNIS
• Type of Device: TORIC IOLS
• 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: 10989092
• MDR Text Key: 220899611
• Report Number: 2648035-2020-00925
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Public: (01)
• Combination Product (y/n): Y
• Reporter Country Code: SG
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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