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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 MICL13.2
Medical Device Problem Code Torn Material (3024)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/10/2016
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Visual inspection of the returned product found a piece of haptic was torn off and missing.The lens was returned in liquid.(b)(4).
 
Event or Problem Description
The reporter stated a piece of haptic from a 13.2mm micl13.2 implantable collamer lens, -9.0 diopter, was torn off as she was advancing the lens forward from the cartridge with a forcep.There was no patient contact.The reporter stated the cause of the event was unknown.
 
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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 Key5724435
Report Number2023826-2016-00813
Device Sequence Number4156
Product Code MTA
UDI-Device Identifier00841542103275
UDI-Public(01)00841542103275(17)171130
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 05/18/2016
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 Date11/30/2017
Device Model NumberMICL13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2016
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/18/2016
Initial Report FDA Received Date06/14/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		N/A
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
INJECTOR MODEL: UNK
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