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

Model Number ZCT150

Device Problems Unintended Movement (3026); Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown as information was not provided.If explanted: not applicable as the iol remains implanted in the patient¿s ocular sinister (left eye).(b)(4).Product testing could not be performed because the product was not returned as the lens remains implanted in the patient¿s ocular sinister (left eye).A product quality deficiency could not be confirmed.The reported issue was not verified.The manufacturing records for the product were reviewed, the product was manufactured and released according to specification.A search revealed that no other complaints for this production order number have been received.As a result, of the investigation there is no indication of a product malfunction or product quality deficiency.The reported issue was not verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported intraocular lens (iol) was placed 074 at degrees (078 was intended) in the patient¿s ocular sinister (left eye).Lens rotated to 085 degrees.Patient had uncomplicated nuclear sclerotic (ns) cataract and regular corneal astigmatism.Post-op results were reported as: 20/40 correctable with +0.75 -1.50 x 85.The patient was unhappy 10 days out from the procedure.Through follow-up, additional information was received stating there was four lines of uncorrected visual acuity (ucva) lost.Patient resulted in 20/40 post-op correctable to 20/15 +0.75 -1.50 x 074, it implies that the refractive error was due to the lens.The lens was rotated on (b)(6) 2020 according to (b)(6).There was no serious patient injury, but the patient was unhappy about the unexpected outcome, (less than expected ucva).Patient vision post rotation is 20/20 ucva.Account is concerned that (b)(6) recommended rotation of 90 degrees, to an axis of 164, which implies that the original calculations from the (b)(6) were off by 90 degrees.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: 10820533
• MDR Text Key: 216676668
• Report Number: 9614546-2020-00476
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474657847
• UDI-Public: (01)05050474657847(17)241216
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ZCT150
• Device Catalogue Number: ZCU150U225
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2019
• 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: 61 YR