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

Model Number	ZCT525
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.It was indicated that the lens is not returning for evaluation as to date it remains implanted; therefore a failure analysis of the complaint device cannot be completed.A review of the device history record, labeling, 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.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.
Event or Problem Description
It was reported that the toric intraocular lens (model zct525 +18.0 diopter) was implanted in the patient's right eye on (b)(6) 2018.The procedure was completed successfully and there were no patient complication and/or related injury reported.The intraocular lens (iol) originally placed at 7 degrees, was measured at 25 degrees one week post-op on (b)(6) 2018.Reportedly, no action has been taken and the lens remains implanted in the eye.No iol repositioning is planned.The outcome does not significantly interferes with the patient''s daily activities.No further information was provided.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): JOHNSON AND JOHNSON SURGICAL VISION, INC.; santa ana CA 92705
• MDR Report Key: 7595332
• Report Number: 9614546-2018-00576
• Device Sequence Number: 11333247
• Product Code: HQL
• UDI-Device Identifier: 05050474603530
• UDI-Public: (01)05050474603530(17)210119
• Combination Product (Y/N): N
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 01/19/2021
• Device Model Number: ZCT525
• Device Catalogue Number: ZCT525U180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR