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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 Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 02/22/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Lens was returned in a small amount of liquid, in a lens vial.Visual inspection found a piece of the haptic missing.(b)(4).
 
Event or Problem Description
The reporter stated that the surgeon implanted a micl13.7 implantable collamer lens, -11.5 diopter, and saw that it was too big.The lens was removed during the same surgery and a smaller lens was implanted.There was no injury to the patient, no enlargement of the incision and no sutures were needed.
 
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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 Key6424882
Report Number2023826-2017-00399
Device Sequence Number19108041
Product Code MTA
UDI-Device Identifier00841542103596
UDI-Public(01)00841542103596(17)170731
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/24/2017
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 Date07/31/2017
Device Model NumberMICL13.7
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/24/2017
Initial Report FDA Received Date03/22/2017
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 # - UNK; INJECTOR MODEL AND LOT # - UNK
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