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

Model Number ZCB00

Device Problem Difficult To Position (1467)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); No Code Available (3191)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

The lens was inserted and removed.(b)(4).All pertinent information available to abbott medical optics has been submitted.

Event Description

It was reported that an intraocular lens (iol) would not position correctly in the eye.Reportedly the lens was cut out of the eye.An undefined patient intervention/injury was reported.No further information was provided.

Manufacturer Narrative

Additional information was received and it was reported that there was no patient injury.The intraocular lens (iol) was removed and replaced during the same surgical procedure.There was no vitrectomy performed and no complications.The patient was reported doing well.This event has now been determined not to be a reportable event.(b)(4).No further reports will be sent for this file.All pertinent information available to abbott medical optics 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: pam mcclain ; 1700 east st. andrew place; santa ana, CA 92705 ; 7142478243
• MDR Report Key: 6347814
• MDR Text Key: 67923901
• Report Number: 2648035-2017-00339
• Device Sequence Number: 1
• Product Code: HQL
• UDI-Device Identifier: 05050474531918
• UDI-Public: (01)05050474531918(17)170216
• 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: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/16/2017
• Device Model Number: ZCB00
• Device Catalogue Number: ZCB0000300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2013
• 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