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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS
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STAAR SURGICAL COMPANY ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS Back to Search Results
Model Number MICL12.6
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/25/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer? no - lens not returned.(b)(4).
 
Event or Problem Description
The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -12.0 diopter, but the surgeon felt the lens was not loaded correctly, so the lens was removed.There was no patient injury and the backup lens was implanted.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
ICL (IMPLANTABLE COLLAMER LENS)
Common Device Name
INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key5905512
Report Number2023826-2016-01160
Device Sequence Number18933484
Product Code MTA
UDI-Device Identifier00841542103060
UDI-Public(01)00841542103060(17)171231
Combination Product (Y/N)N
Initial Reporter StateUT
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 health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/26/2016
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
Operator of Device Physician
Device Expiration Date12/31/2017
Device Model NumberMICL12.6
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/26/2016
Initial Report FDA Received Date08/26/2016
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
INJECTOR MODEL MSI-PF - LOT NUMBER UNK
Patient Age26 YR
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