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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS Back to Search Results
Model Number TMICL12.6
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Patient Involvement (2645)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Lens was returned in liquid, in lens vial.Visual inspection found one of the haptics torn.No similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that a 12.6mm, tmicl12.6, -11.0/2.5/064 (sphere/cylunder/axis), implantable collamer lens tore while loading.There was no patient contact.The backup lens was implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Common Device Name
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
MDR Report Key9722922
Report Number2023826-2020-00336
Device Sequence Number2422148
Product Code QCB
UDI-Device Identifier00841542107013
UDI-Public00841542107013
Combination Product (Y/N)N
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) 01/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2021
Device Model NumberTMICL12.6
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/22/2020
Initial Report FDA Received Date02/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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