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

Model Number	ZCT400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	06/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as the lens remains implanted.(b)(4)- repositioned lens in a secondary procedure.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.
Event or Problem Description
It was initially reported that after implantation of zct400 18.5 diopter intraocular lens (iol) in a male patient's left eye; the patient experienced a 50° axis misalignment in the left eye.However, through follow up it was learned that this initial information was incorrect.Additional information was received and it was clarified/learned that the patient complained of visual distortion.Patient's uncorrected visual acuity at 1- month postoperative visit was 20/40 and best corrected visual acuity was 20/20.Patient feels that the left eye has a weaker vision than the right eye.Furthermore, it was learned that the zct400 lens was placed at 004 degrees based on ocular response analyzer (ora) on (b)(6) 2016.Ora was incorrect and lens should have been placed at 170 degrees per amo toric calculator.The lens was repositioned to the correct placement of 172 degrees on (b)(6) 2016.Patient's vision at 1-day post repositioning was 20/20.No further information was provided.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6586602
• Report Number: 9614546-2017-00454
• Device Sequence Number: 18854914
• Product Code: HQL
• UDI-Device Identifier: 05050474553880
• UDI-Public: (01)05050474553880(17)161210
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/23/2017

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: 12/10/2016
• Device Model Number: ZCT400
• Device Catalogue Number: ZCT400U185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/23/2017
• 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
• Patient Age: 68 YR