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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 MICL13.2
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem No Patient Involvement (2645)
Event Date 12/18/2019
Event Type  malfunction  
Manufacturer Narrative
No similar complaint was reported for units within the same lot.(b)(4).
 
Event Description
The reporter indicated the surgeon removed a 13.2mm micl13.2 implantable collamer lens, -9.5 diopter, from the vial and was preparing the lens to load into the cartridge.The reporter indicated the lens felt harder than normal and was difficult to load.There was no patient contact.The backup lens was implanted with no problem.
 
Manufacturer Narrative
H3 - device evaluation: lens was returned in a vial in liquid.Visual inspection found no visible damage to the 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 91016
MDR Report Key9535967
MDR Text Key191265428
Report Number2023826-2019-02500
Device Sequence Number1
Product Code MTA
UDI-Device Identifier00841542103282
UDI-Public00841542103282
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 12/18/2019
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
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Model NumberMICL13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2020
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received12/31/2019
Supplement Dates Manufacturer Received08/18/2020
Supplement Dates FDA Received08/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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