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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS
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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC INTRAOCULAR LENS Back to Search Results
Model Number MICL 13.7
Device Problem Difficult to Fold, Unfold or Collapse (1254)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
One similar complaint type events were reported for units within the same lot.(b)(4).
 
Event Description
The reporter indicated that a 13.7mm, micl 13.7, -10.5 diopter, implantable collamer lens was to be implanted into the patient's left eye (os)."surgeon did not like the way the lens was loaded or unfolding as it reached the end of the cartridge." the back-up lens was instead implanted.Reportedly the initial "lens never came in contact with the patient.".
 
Manufacturer Narrative
Additional information: h3- lens returned in liquid in a lens vial.Visual inspection found no visible damage to lens.Claim#(b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia, ca
MDR Report Key9824665
MDR Text Key191265849
Report Number2023826-2020-00449
Device Sequence Number1
Product Code MTA
UDI-Device Identifier00841542103572
UDI-Public00841542103572
Combination Product (y/n)N
PMA/PMN Number
P030016
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Model NumberMICL 13.7
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2020
Date Manufacturer Received05/15/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTRIDGE MODEL#SFC-45, LOT#UNK; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK
Patient Age28 YR
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