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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 Codes Misfocusing (1401); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes Blurred Vision (2137); Visual Disturbances (2140); No Code Available (3191)
Date of Event 10/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, race:unk.(b)(4).Lens work order search: 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 13.2mm tmicl13.2 lens, -7.0/+4.0/112 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2019.On (b)(6) 2019 the lens was explanted due to blurred vision, double-vision, and near vertical rotation of lens.Attempts to obtain additional information have not been successful.
 
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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 Key9246802
Report Number2023826-2019-02026
Device Sequence Number305442
Product Code QCB
UDI-Device Identifier00841542108652
UDI-Public00841542108652
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) 10/08/2019
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 Date07/31/2021
Device Model NumberTMICL13.2
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/08/2019
Initial Report FDA Received Date10/28/2019
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 Age33 YR
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