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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number MICL13.7
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/18/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned product found one haptic torn.The lens was returned in liquid.Work order search: no similar complaints were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter stated the surgeon inserted and removed a 13.7mm micl13.7 implantable collamer lens, -10.0 diopter, on (b)(6) 2016.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Common Device Name
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key6415466
Report Number2023826-2017-00340
Device Sequence Number532741
Product Code MTA
UDI-Device Identifier00841542103565
UDI-Public(01)00841542103565(17)180531
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Device Explanted Year2016
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/16/2017
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
Operator of Device Physician
Device Expiration Date05/31/2018
Device Model NumberMICL13.7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/16/2017
Initial Report FDA Received Date03/17/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
CARTRIDGE MODEL AND LOT NUMBER UNK; INJECTOR MODEL AND LOT NUMBER UNK
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