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

Model Number	ZCT300
Medical Device Problem Codes	Unintended Movement (3026); Device Handling Problem (3265)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	08/09/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as to date the lens remains implanted.(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported on that on (b)(6) 2016, the surgeon implanted a zct300 intraocular lens (iol) in the left (os) eye of a female patient on the wrong axis (of 168 degrees) and realized his mistake postoperatively.Intended axis from amo toric calculator was 92 degrees.The patient required a secondary surgical intervention to reposition the lens.The patient reported that her vision was a little blurry one (1) day postoperatively.It was reported that no other complication is reported by the patient to date.The (ucva) uncorrected visual acuity (snellen chart) was 20/100 one (1) day postoperatively.On (b)(6) 2016 (10 days post op), the patient returned for a visit to measure the lens axis prior to the repositioning surgery.The patient axis was measured and it revealed a 12 degrees rotation (from 168 to 180).Hence, lens repositioning was scheduled and it occurred on (b)(6) 2016 and patient was fine/doing well post-operation.No other information was provided.
Additional Manufacturer Narrative
Device evaluation: the device was not returned to the manufacturer for evaluation.Device inspection could not be performed, therefore the reported complaint could not be verified.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no similar complaints were received for this order number to date.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the intraocular lenses.Based on the investigation results there is no indication of a product quality deficiency.All pertinent information available to abbott medical optics has been submitted.

• Brand Name: TECNIS
• Common Device Name: TORIC IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 5947057
• Report Number: 9614546-2016-00455
• Device Sequence Number: 415016
• Product Code: HQL
• UDI-Device Identifier: 05050474553286
• UDI-Public: (01)05050474553286(17)190908
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2016

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: 09/08/2019
• Device Model Number: ZCT300
• Device Catalogue Number: ZCT300U180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2016
• Supplement Report FDA Received Date: 12/27/2016
• 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: 69 YR