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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES SURGICAL ADJUNCTS

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ABBOTT MEDICAL OPTICS PLATINUM 1 SERIES SURGICAL ADJUNCTS Back to Search Results
Model Number 1MTEC30
Device Problems Difficult or Delayed Positioning; Device Operates Differently Than Expected
Event Date 11/28/2016
Event Type  Malfunction  
Manufacturer Narrative

If implanted, give date: not applicable, as this is not an implantable device if explanted, give date: not applicable. Not an implantable device, therefore not explanted. All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that when inserting a zxr00 23. 0 diopter intraocular lens into the eye, the lens was damaged due to cartridge working improperly. The customer was not sure what the specific issue was with the cartridge, just knew that the cartridge did not work properly. The lens got damaged, and was torn in half as it passed through the cartridge. There was an incision enlargement, but no vitrectomy. No patient injury post-op. No further information was provided.

 
Manufacturer Narrative

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. The directions for use (dfu) was reviewed. The dfu adequately provides instructions and precautions for the proper use and handling of the product. Based on the investigation results there is no indication of a product quality deficiency. All pertinent information available to the manufacturer has been submitted.

 
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Brand NamePLATINUM 1 SERIES
Type of DeviceSURGICAL ADJUNCTS
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 Key6197249
Report Number2648035-2016-02079
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/10/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date09/12/2019
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCB39355
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/18/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/12/2016
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: 12/21/2016 Patient Sequence Number: 1
Treatment
ZXR00U0230-SN#(B)(4)
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