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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 No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/01/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No similar complaint was reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated a 13.2mm micl13.2 implantable collamer lens, -11.5 diopter, was torn while being pulled into the super funnel cartridge.There was no patient contact.The backup lens was implanted.
 
Additional Manufacturer Narrative
The lens was returned in liquid in a vial.Visual inspection found one haptic torn.(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 Key8158123
Report Number2023826-2018-01788
Device Sequence Number1630680
Product Code MTA
UDI-Device Identifier00841542103329
UDI-Public00841542103329
Combination Product (Y/N)N
Initial Reporter StateCO
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,Followup
Report Date (Section B) 11/14/2018
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 Date07/31/2020
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/17/2018
Initial Date Received by Manufacturer 11/14/2018
Supplement Date Received by Manufacturer12/17/2018
Initial Report FDA Received Date12/12/2018
Supplement Report FDA Received Date12/19/2018
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 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
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