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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 MICL12.1
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/28/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Pt info: unk.Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
 
Event or Problem Description
The reporter indicated a 12.1mm micl12.1 implantable collamer lens, -07.00 diopter, tore during loading and there was no patient contact.Additional information has been requested but none has been forthcoming.
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Common Device Name
PHAKIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key12437088
Report Number2023826-2021-03477
Device Sequence Number19761399
Product Code MTA
UDI-Device Identifier00841542102698
UDI-Public00841542102698
Combination Product (Y/N)N
Initial Reporter StateHI
Initial Reporter CountryUS
PMA/510(K) Number
P030016
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/13/2021
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 Date02/28/2023
Device Model NumberMICL12.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/13/2021
Initial Report FDA Received Date09/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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