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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
Date of Event 09/19/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that a 13.2mm tmicl13.2, -8.0/3.0/067 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (od) on (b)(6) 2019.On (b)(6) 2019 the lens was repositioning was performed due to lens rotation not associated to low vault but it did not resolve the problem.On (b)(6) 2019 the lens was exchanged for non toric lens and the problem resolved.
 
Additional Manufacturer Narrative
Device evaluation: lens was returned dry with clear surgical residue in a contact lens container.Visual inspection found no visible damage and foreign residue on the lens.Claim#: (b)(4).
 
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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 91016
MDR Report Key9176657
Report Number2023826-2019-01896
Device Sequence Number3447773
Product Code QCB
UDI-Device Identifier00841542108775
UDI-Public00841542108775
Combination Product (Y/N)N
Initial Reporter StateOK
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/11/2019
1 Device was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date09/30/2020
Device Model NumberTMICL13.2
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2019
Initial Date Received by Manufacturer 09/11/2019
Supplement Date Received by Manufacturer11/06/2019
Initial Report FDA Received Date10/10/2019
Supplement Report FDA Received Date11/19/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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