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

Model Number	ZCT450
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If explanted, give date: not applicable as to date the lens remains implanted and therefore not explanted.(b)(4).Lens repositioned in a secondary procedure.All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a toric intraocular lens (iol) was implanted in the right eye of a (b)(6)year-old (b)(6) patient.At the two weeks post-op visit of the companion lens implant, it was noted that a lens misalignment of 12 degrees from the original position was noted.The lens was originally placed at 102 degrees and was noted at 90 degrees during the slit lamp exam.There were no patient complications or related injuries.Additional information was received and it was learnt that the lens repositioning was planned for (b)(6) 2016; however, the doctor performed the lens repositioning on (b)(6) 2016.Reportedly the patient has recovered.No further information was provided.The patient also has a lens implanted in her left eye.A separate mdr will be filed for this lens.
Additional Manufacturer Narrative
Device evaluation: the intraocular lens (iol) was not returned to the manufacturing site for investigation as it remains implanted.An investigation could therefore, not be performed.The customer's reported event could not be confirmed.Manufacturing record review: a review of the manufacturing records was performed.The documentation shows that the production order was manufactured according to specifications.A search of complaints revealed that no similar complaints were received for this production order number.Labeling review: the directions for use (dfu) were reviewed.The dfu adequately provides instructions, precautions, and warnings for the proper use and handling of the intraocular lenses.Based on the results of the investigation, no product deficiency was identified.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: 6192049
• Report Number: 9614546-2016-00699
• Device Sequence Number: 16270737
• Product Code: HQL
• UDI-Device Identifier: 05050474603028
• UDI-Public: (01)05050474603028(17)200617
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 02/06/2017

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: 06/17/2020
• Device Model Number: ZCT450
• Device Catalogue Number: ZCT450U220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2016
• Supplement Report FDA Received Date: 02/07/2017
• 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