• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS UNKNOWN SURGICAL ADJUNCTS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT MEDICAL OPTICS UNKNOWN SURGICAL ADJUNCTS Back to Search Results
Model Number UNKNOWN
Device Problems Bent; Difficult or Delayed Positioning; Positioning Failure
Event Date 12/14/2017
Event Type  Malfunction  
Manufacturer Narrative

The product is not implantable. The lot number was not provided. (b)(4). All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that an unknown cartridge model cracked down the center lengthwise from the bottom of the cartridge to the tip during handling and prior to insertion. In addition, the za9003 23. 5 diopter intraocular lens (iol) became stuck in the cartridge, which caused a haptic to crimp. There was no patient contact. No additional information was provided.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameUNKNOWN
Type of DeviceSURGICAL ADJUNCTS
Manufacturer (Section D)
ABBOTT MEDICAL OPTICS
santa ana CA 92705
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 Key7182184
Report Number2648035-2017-02392
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 01/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/11/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device MODEL NumberUNKNOWN
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/11/2018 Patient Sequence Number: 1
Treatment
ZA9003 23.5 DIOPTER IOL, S/N (B)(4)
-
-