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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 MICL13.2
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Device evaluation- lens was received dry, in a small envelope.Visual inspection found a torn haptic and residue on the lens surface, torn haptic piece is missing.(b)(4).
 
Event or Problem Description
The reporter stated that a 13.2 mm micl13.2, -16.0 diopter, implantable collamer lens was explanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch 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 Key7789908
Report Number2023826-2018-01236
Device Sequence Number19441328
Product Code MTA
UDI-Device Identifier00841542103411
UDI-Public00841542103411
Combination Product (Y/N)N
Initial Reporter StateVA
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 Health Care Professional
Type of Report Initial
Report Date (Section B) 07/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date06/30/2019
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/17/2018
Initial Report FDA Received Date08/16/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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