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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 VTICM5_12.6
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems No Code Available (3191); Missing Value Reason (3192)
Event Date 07/21/2018
Event Type  Injury  
Manufacturer Narrative
This product is not marketed in the us.(b)(4).
 
Event Description
The reporter indicated that a 12.6mm, vticm5_12.6, -12.00/+2.5/094 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2018.Lens rotation not associated to a low vault was observed.On (b)(6) 2018 the lens was repositioned but it did not resolve the problem.On (b)(6) 2018 the lens was exchanged for a longer length lens and the problem was resolved.
 
Manufacturer Narrative
(b)(4).Lens was returned dry, in a micro-centrifuge vial.Visual inspection found the haptic torn and presence of residue on lens surface.(b)(4).
 
Manufacturer Narrative
(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
Manufacturer (Section G)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
Manufacturer Contact
cynthia thai
1911 walker avenue
monrovia, CA 91016
MDR Report Key8041444
MDR Text Key126234136
Report Number2023826-2018-01590
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/10/2018
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 Date02/28/2021
Device Model NumberVTICM5_12.6
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/10/2018
Initial Date FDA Received11/06/2018
Supplement Dates Manufacturer Received12/24/2018
01/14/2019
Supplement Dates FDA Received01/02/2019
01/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age23 YR
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