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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL OPTICS EMERALD; SURGICAL ADJUNCTS

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ABBOTT MEDICAL OPTICS EMERALD; SURGICAL ADJUNCTS Back to Search Results
Model Number EMERALDC30
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).All pertinent information available to abbott medical optics has been submitted.
 
Event Description
On (b)(6) 2016, it was reported by the physician that there continues to be faint and short "brush stroke type" marks on the intraocular lens (iol) posterior surface of the optic, near the leading haptic/optic junction.They are always in the same place and they occur on most of the iols this customer implants.Reportedly, the marks are only noticeable after the lens is in the bag.The physician can't see the marks when he inspects the lens before loading the cartridge.He thinks the cartridge is the culprit and the new cartridges have a slightly narrower cannula perhaps or an internal edge at the opening.The marks are more noticeable on the higher powered lenses.The marks are visually inconsequential to the patient and no explants are planned since they are well outside the visual axis.No further information was provided.
 
Manufacturer Narrative
Device evaluation: complaint device was not returned to the manufacturer for investigation.Therefore, the reported issue of cartridge tip damaged could not be verified.The manufacturing records evaluation and the search for same/similar issue could not be performed since the device lot number was not provided.During manufacturing process, all cartridges are inspected and accepted per the inspection criteria.A historical complaint data review was performed and results did not identify any product deficiency.A search within global quality management system was performed and there were no related deviations or non-conformity.The directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Based on the historical complaint review, non-conformance review and labeling review, there is no indication of a malfunction or product deficiency.All pertinent information available to abbott medical optics has been submitted.
 
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Brand Name
EMERALD
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 1408
anasco PR 00610
Manufacturer Contact
pam mcclain
1700 east st. andrew place
santa ana, CA 92705
7142478243
MDR Report Key5498192
MDR Text Key40247474
Report Number2648035-2016-00373
Device Sequence Number1
Product Code KYB
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K961242
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/17/2016
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 Model NumberEMERALDC30
Device Catalogue NumberEMERALDC30
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/15/2016
Initial Date FDA Received03/14/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/17/2016
Was Device Evaluated by Manufacturer? Yes
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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