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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; PHAKIC TORIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; 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 Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lens was returned dry in a lens case.There was clear surgical residue on the lens surface.Visual inspection found that the haptic was torn.No similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that as the surgeon was loading a 12.6mm tmicl12.6 implantable collamer lens, -10.0/+1.0/088 (sphere/cylinder/axis) it tore.Attempts to obtain additional information have not been successful.
 
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Brand Name
IMPLANTABLE COLLAMER LENS
Common Device Name
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
MDR Report Key10335345
Report Number2023826-2020-01531
Device Sequence Number14346282
Product Code QCB
UDI-Device Identifier00841542106849
UDI-Public00841542106849
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 company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/30/2020
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 Date09/30/2020
Device Model NumberTMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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