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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 MICL12.6
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/27/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lens was returned in liquid in a cartridge case.Visual inspection found one haptic torn.No similar complaint was reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated a 12.6mm micl12.6 implantable collamer lens, -11.5 diopter, was torn during the loading process, as the lens was being pulled through the cartridge.There was no patient contact and the backup lens was implanted with no problem.The reporter indicated the cause of the event was unknown.
 
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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 Key8204888
Report Number2023826-2018-01927
Device Sequence Number202304
Product Code MTA
UDI-Device Identifier00841542103053
UDI-Public00841542103053
Combination Product (Y/N)N
Initial Reporter StateOH
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) 12/03/2018
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 Health Professional
Device Expiration Date04/30/2020
Device Model NumberMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/03/2018
Initial Report FDA Received Date12/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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