MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS 1-PIECE; MONOFOCAL IOLS

Model Number	ZCB00
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/15/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
Event or Problem Description
It was reported that a physician implanted a zcb00 14.5 diopter intraocular lens (iol) on a patient's right eye.However, the physician was aiming for plano thus requiring a lens exchange for zcb00 10.5 diopter iol.Through follow-up it was learned that the patient¿s symptoms significantly affects his daily activities.Prior to explant the lens had rotated 20 degrees counterclockwise.Lens was replaced with a zcb00 10.5 diopter iol.There was no incision enlargement or vitrectomy required.Patient prescribed besivance 1drop 3x/day for 1 week, lotemax gel 1 drop 3x/day for 4 weeks, prolensa 1 drop 1x/day for 4 weeks.Patient is doing good after the replacement.Patient's visual acuity: visual acuity pre-op (pre-initial implant): 20/60-2.Visual acuity post-op (post-initial implant): 20/400.Visual acuity post-op (post-replacement): 20/30-.It was indicated that the explanted lens is not available for returned product evaluation.
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 additional investigation request 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 the manufacturer has been submitted.

• Brand Name: TECNIS 1-PIECE
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6281552
• Report Number: 2648035-2017-00188
• Device Sequence Number: 161935
• Product Code: HQL
• UDI-Device Identifier: 05050474531604
• UDI-Public: (01)05050474531604(17)200418
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P980040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2017

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: 04/18/2020
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/03/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/26/2017
• Supplement Report FDA Received Date: 03/01/2017
• 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: 72 YR