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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 VICMO12.1
Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
This product is not marketed in the us.Medical device problem code - use (acd < 3.0mm).Claim # (b)(4).
 
Event Description
The reporter indicated that a 12.1mm, vicmo12.1, -9.50 diopter, implantable collamer lens was implanted into the patient's left eye (os) on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged for a longer length lens due to low vault.This exchange resolved the problem.
 
Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in a micro centrifuge vial with moisture on the lens.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 Key11093457
MDR Text Key224252432
Report Number2023826-2020-03265
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 12/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date04/30/2023
Device Model NumberVICMO12.1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Initial Date Manufacturer Received 12/01/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received06/04/2021
Supplement Dates FDA Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNK.
Patient Outcome(s) Required Intervention;
Patient Age32 YR
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