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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 Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown, not provided.If implanted, give date: not applicable as this is not an implantable device.If explanted, give date: not applicable as this is not an implantable device.All pertinent information available to abbott medical optics has been submitted.
 
Event Description
It was reported that some sort of material came out when the surgeon injected an intraocular lens (iol) in the patient's eye.Reportedly, the foreign material was usually behind the lens, it has multicolor and looked like an oil slick on a puddle.It was almost like dried viscoelastic or old capsule material or something like that.The foreign material was removed with an instrument.It kind of fell apart, it was brittle.There were no patient complications.The surgeon commented that this issue occurred on multiple cases with amo lenses zcb00 and multifocal lenses, injected with 1mtec30 cartridges (lots cc10472 and cc10763).Four (4) mdrs will be submitted.This report is for the cartridge 1mtec30 with lot cc10763.
 
Manufacturer Narrative
Device evaluation: the cartridge was not returned at the manufacturing site; therefore product testing could not be performed and the customer's reported complaint could not be verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.The product was manufactured and released according to specification.A search revealed that no additional complaints for this order number have been received.Labeling review: the directions for use (dfu) were reviewed.The directions for use (dfu) adequately provides instructions and precautions along with warnings for the proper use and handling of the device.As a result of the investigation, there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to abbott medical optics has been submitted.
 
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Brand Name
PLATINUM 1 SERIES
Type of Device
SURGICAL 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 Key7076342
MDR Text Key93869370
Report Number2648035-2017-02199
Device Sequence Number1
Product Code KYB
UDI-Device Identifier05050474540323
UDI-Public(01)05050474540323(17)180830(10)CC10763
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date08/30/2018
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCC10763
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/03/2017
Initial Date FDA Received12/01/2017
Supplement Dates Manufacturer Received01/22/2018
Supplement Dates FDA Received02/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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