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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 TMICL13.2
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/03/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: the lens was returned in liquid in lens vial.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 the surgeon was attempting to insert a 13.2mm tmicl13.2 implantable collamer lens, -14.00/+1.0/040 (sphere/cylinder/axis), in the patients left eye (os) and noted the lens was torn before implanting.The backup lens was used.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch 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 Key10242498
Report Number2023826-2020-01421
Device Sequence Number16765462
Product Code QCB
UDI-Device Identifier00841542109574
UDI-Public00841542109574
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) 06/09/2020
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 Date01/31/2022
Device Model NumberTMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/09/2020
Initial Report FDA Received Date07/07/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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