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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 MICL12.1
Medical Device Problem Code Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code No Code Available (3191)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).Work order search: no similar complaints were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated the surgeon inserted a 12.1mm micl12.1 implantable collamer lens, -14.5 diopter, and the lens was torn.The lens was removed during the same surgery with no patient injury.The backup lens was implanted and a suture was required.The cause of the event was unknown.
 
Additional Manufacturer Narrative
(b)(4).
 
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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 Key6681413
Report Number2023826-2017-01099
Device Sequence Number11166673
Product Code MTA
UDI-Device Identifier00841542102841
UDI-Public00841542102841
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
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 06/14/2017
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 Physician
Device Expiration Date04/30/2018
Device Model NumberMICL12.1
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 06/14/2017
Supplement Date Received by Manufacturer09/13/2017
Initial Report FDA Received Date06/30/2017
Supplement Report FDA Received Date09/13/2017
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 SFC-45 FP - LOT NUMBER UNK; FOAM TIP PLUNGER MODEL FTP - LOT NUMBER UNK; INJECTOR MODEL MSI-PF - LOT NUMBER UNK
Outcome Attributed to Adverse Event Required Intervention;
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