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

Model Number	ZCT150
Medical Device Problem Codes	Unintended Movement (3026); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e. st. andrew place; santa ana CA 92705
• MDR Report Key: 10820533
• Report Number: 9614546-2020-00476
• Device Sequence Number: 11291021
• Product Code: HQL
• UDI-Device Identifier: 05050474657847
• UDI-Public: (01)05050474657847(17)241216
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/10/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2024
• Device Model Number: ZCT150
• Device Catalogue Number: ZCU150U225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR