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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 Problem Bent
Event Type  Malfunction  
Manufacturer Narrative

All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that the cartridge tip was bent when the user opened the carton and that the intraocular lens (iol) got stuck inside the cartridge no additional information was provided to abbott medical optics.

 
Manufacturer Narrative

Device available for evaluation? yes, returned to manufacturer on 8/28/2017. Device returned to manufacturer? yes. Device evaluation: the returned 1mtec30 cartridge was received inside a pouch in a bag with a zxr00 lens case. The cartridge was observed under the microscope at 10x magnification, and residues of what appears to be viscoelastic were observed only in the cartridge tube. Viscoelastic residues were not observed in the loading zone of the cartridge. The cartridge tube was observed broken by one side with part of the lens out. A lens was observed stuck in the cartridge tip with part of the haptic out. The complaint was verified; however, the cartridge breakage could appear to be caused by the pushrod handpiece due the scarce amount of viscoelastic observed. Manufacturing records review: the manufacturing records for the product were reviewed. The product was manufactured and released according to specifications. Labeling review: the directions for use (dfu) were reviewed. The dfu provide the customer with proper usage instructions and guidelines. Conclusion: as a result of the investigation, there is no indication of a product quality deficiency. All pertinent information available to abbott medical optics 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
pamela mcclain
1700 east st. andrew place
santa ana , CA 92705
7142478243
MDR Report Key6860793
Report Number2648035-2017-01643
Device Sequence Number1
Product CodeKYB
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 10/08/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/12/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date05/19/2018
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCC05983
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/28/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/13/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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