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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)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Age, sex, weight, ethnicity, race: unk.Date of event: unk.Implanted: unk.Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).
 
Event or Problem Description
It was reported that a 13.2mm tmicl13.2 implantable collamer lens, -12.00/+3.5/076 (sphere/cylinder/axis) is scheduled to be exchanged with a shorter length lens.Reportedly, the lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.
 
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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 Key9072242
Report Number2023826-2019-01658
Device Sequence Number19773623
Product Code QCB
UDI-Device Identifier00841542109345
UDI-Public00841542109345
Combination Product (Y/N)N
Initial Reporter StateGA
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) 08/26/2019
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 Date06/30/2021
Device Model NumberTMICL13.2
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/26/2019
Initial Report FDA Received Date09/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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