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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 Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Device evaluation: the cartridge was returned at the manufacturing site for evaluation.Visual inspection using a 10x microscope magnification showed residues of viscoelastic solution (ovd) on the cartridge indicating that the unit was handled and prepare for surgical use.A crack was observed at the cartridge tip area.The customer's reported complaint was verified.Manufacturing records review: the manufacturing records for the cartridge were reviewed.During the manufacturing process the operators check the neck, tube and tip areas for cracks.No cracking or stress marks are allowed.They also check the tip for any melting, roughness, dent, bent tip or smash condition.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 was verified.All pertinent information available to abbott medical optics has been submitted.
 
Event Description
It was reported that during implantation of an intraocular lens (iol), the injector penetrated through the cartridge.A fragment from the cartridge entered the eye together with the lens and it was removed eventually without any patient injury.No further information was provided.
 
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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 Key6146440
MDR Text Key61493785
Report Number2648035-2016-01925
Device Sequence Number1
Product Code KYB
UDI-Device Identifier05050474540323
UDI-Public(01)05050474540323(17)170705(10)CB35531
Combination Product (y/n)N
Reporter Country CodeSG
PMA/PMN Number
K081545
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 12/05/2016
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 Date07/05/2017
Device Model Number1MTEC30
Device Catalogue Number1MTEC30
Device Lot NumberCB35531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/09/2016
Initial Date FDA Received12/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/05/2016
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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