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

Model Number Z9002

Device Problems Difficult To Position (1467); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).All pertinent information available to the manufacturer has been submitted.

Event 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.

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
• Type of Device: MONOFOCAL IOLS
• Manufacturer (Section D): ABBOTT MEDICAL OPTICS; santa ana CA
• Manufacturer (Section G): ABBOTT MEDICAL OPTICS INC.; road 402 north, km 4.2; anasco industrial park, pob 14; anasco PR 00610
• Manufacturer Contact: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6382641
• MDR Text Key: 69202305
• Report Number: 2648035-2017-00419
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474530645
• UDI-Public: (01)05050474530645(17)210222
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR