MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS; TORIC IOLS

Model Number	ZCT150
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Vitrectomy (2643); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to the manufacturer has been submitted.
Event or Problem Description
It was reported that after implantation of a zct150 23.5 diopter intraocular lens (iol), the lens had rotated about 45 degrees and iol is off by a diopter.Furthermore, the physician indicated having some complications regarding removal of lens.The lens was replaced with a 3 piece lens.No further information provided.
Additional Manufacturer Narrative
Additional information: through follow-up it was confirmed that the lens was removed because the iol had rotated post-op.At day one patient was 20/25 along the corrected axis.The lens shifted 45 degrees resulting in the refractive error.The patient finally decided on rotation versus exchanging the iol a year later.One haptic was too fibrosis in to rotate the lens and attempts to explant caused some zonular dehiscence.Therefore, the haptic was cut off and left behind.Anterior vitrectomy was required as vitreous prolapsed forward around the area of zonular dehiscence.No further issues reported at this time.Gender/sex: female.(b)(4).Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported issue could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed that no similar complaints were received for this production order number.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the device.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to the manufacturer has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6655685
• Report Number: 9614546-2017-00550
• Device Sequence Number: 1285228
• Product Code: HQL
• UDI-Device Identifier: 05050474552210
• UDI-Public: (01)05050474552210(17)200510
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2017

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: Physician
• Device Expiration Date: 05/10/2020
• Device Model Number: ZCT150
• Device Catalogue Number: ZCT150U235
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 07/17/2017
• 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