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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/15/2017
Event Type  Malfunction  
Manufacturer Narrative

The cartridge is not an implantable device; therefore, not explanted. All pertinent information available to abbott medical optics has been submitted.

 
Event Description

It was reported that the doctor had approximately 8 cases with the platinum cartridge where he noted a transparent "filament" type of substance coming out of the cartridge that was attaching itself to the trailing haptic during the implantation/delivery process. Once they changed cartridge lot number, without making changes to the surgical technique, this did not occur with the rest of the cases. The substance that came out of the cartridge with the intraocular lens was very fine, clear, wrinkled membrane-like (similar to capsule or descemet's). The doctor was able to use irrigation/aspiration to remove the substance out of the eye in each case. No additional information was provided to abbott medical optics. Note: 8 mdr¿s are being submitted for the 8 reported cases. This is mdr 6 out of 8.

 
Manufacturer Narrative

Device evaluation: the product was not returned for investigation. The reported complaint was not verified. 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 Key6847378
MDR Text Key85143748
Report Number2648035-2017-01609
Device Sequence Number1
Product Code KYB
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/21/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator
Device EXPIRATION Date06/30/2018
Device MODEL Number1MTEC30
Device Catalogue Number1MTEC30
Device LOT NumberCC08053
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 Received11/22/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/30/2017
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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