MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS TECNIS CL; MONOFOCAL IOLS

Model Number	Z9002
Medical Device Problem Codes	Difficult To Position (1467); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2017
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 the intraocular lens (iol) was removed and replaced during the initial procedure.This lens was a replacement lens for an earlier lens explant.During the procedure, the lens went into the eye upside down.The doctor tried to fix it but the lens could not seem to stay centered in the bag.The lens continued to be decentered.This lens was removed and replaced with a non-amo device.There was no incision enlargement and no vitrectomy or patient post-op injury reported.No further information was provided.This report captures serial number (b)(4) and a separate mdr report will be filed for the explanted lens.
Additional Manufacturer Narrative
Device available for evaluation ¿ yes, returned to manufacturer on 04/10/2017 device returned to manufacturer ¿ yes.Device evaluation: the device was returned to the manufacturer.Device inspection was performed and the lens was observed under microscope where viscoelastic residue and particles were observed.No damage was observed in the lens optic zone or in the haptics.The customer's reported issue could not be confirmed in the returned lens sample.Manufacturing records were reviewed and the lens was manufactured according to specification.A search on complaints revealed no other 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 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 CL
• Common Device Name: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• MDR Report Key: 6382641
• Report Number: 2648035-2017-00419
• Device Sequence Number: 528483
• Product Code: HQL
• UDI-Device Identifier: 05050474530645
• UDI-Public: (01)05050474530645(17)210222
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P880081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2017

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: 02/22/2021
• Device Model Number: Z9002
• Device Catalogue Number: Z900200175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 05/30/2017
• 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: 82 YR