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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 08/08/2017
Event Type  Malfunction  
Manufacturer Narrative

Implant and explant dates: if implanted or explanted; give date: n/a (not applicable). The cartridge is not an implantable device; therefore, not explanted. 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. A search revealed that no additional investigation requests for this order number have been received. 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.

 
Event Description

It was reported that when injecting the intraocular lens (iol), the doctor noticed that there was a stringy cellophane-like film left on the optic. He feels it may be some of the residual inner coating on the platinum cartridge being injected into the eye with the iol. He was able to remove the stringy film with irrigation/aspiration. No patient harm was reported. No additional information was provided to abbott medical optics.

 
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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 Key6843591
MDR Text Key84987557
Report Number2648035-2017-01593
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 HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial
Report Date 09/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/05/2017
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 NumberCC04220
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 Received08/10/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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