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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 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 03/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 13.2mm tmicl13.2 implantable collamer lens, -11.0/+4.0/092 (sphere/cylinder/axis) into the injector, the haptic broke."no injury to patient" is noted.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 91016
MDR Report Key8563074
Report Number2023826-2019-00709
Device Sequence Number19216779
Product Code QCB
UDI-Device Identifier00841542109215
UDI-Public00841542109215
Combination Product (Y/N)N
Initial Reporter StateOR
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) 04/05/2019
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 NumberTMICL13.2
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/05/2019
Initial Report FDA Received Date04/29/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age34 YR
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