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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 Codes Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/17/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The lens was returned liquid, in a lens vial and ziploc bag.Visual inspection found no visual damage to the lens.(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm tmicl12.6 lens, -14.0/+2.5/093 (sphere/cylinder/axis) into the patient's right (od) eye on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged with a longer lens due to low vault.The problem was resolved.
 
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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 Key8941303
Report Number2023826-2019-01566
Device Sequence Number2088133
Product Code QCB
UDI-Device Identifier00841542107433
UDI-Public00841542107433
Combination Product (Y/N)N
Initial Reporter StateCA
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 company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/31/2019
1 Device was Involved in the Event
1 Patient 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 Date05/31/2021
Device Model NumberTMICL12.6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/31/2019
Initial Report FDA Received Date08/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age48 YR
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