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

Model Number ZCB00

Device Problem Difficult To Position (1467)

Patient Problems Injury (2348); No Code Available (3191)

Event Date 08/24/2016

Event Type  Injury  

Manufacturer Narrative

If implanted; give date: n/a (not applicable).The intraocular lens was removed and replaced.If explanted; give date: n/a (not applicable).The intraocular lens was removed and replaced.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

The intraocular lens (iol) would not place correctly in the eye.It had to be taken out of the eye in pieces.Undefined surgical intervention and injury were reported.No additional information was provided to abbott medical optics.

Manufacturer Narrative

Additional information: through follow-up, it was confirmed that the implant was simply removed and replaced during the time of surgery.There were no complications or vitrectomy performed.There was no patient injury reported and the patient is doing well.No further information was provided.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 investigations requested for this po number.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
• 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: pamela mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6356682
• MDR Text Key: 68269865
• Report Number: 2648035-2017-00364
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531758
• UDI-Public: (01)05050474531758(17)190711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/11/2019
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2015
• 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