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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STAAR SURGICAL COMPANY VISIAN ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS

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STAAR SURGICAL COMPANY VISIAN ICL (IMPLANTABLE COLLAMER LENS); INTRAOCULAR LENS Back to Search Results
Model Number VICMO12.1
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Intraocular Pressure Increased (1937); Vomiting (2144); No Code Available (3191)
Event Date 01/15/2015
Event Type  Injury  
Event Description
The reporter indicated the surgeon implanted a 12.1mm vicmo12.1 implantable collamer lens in the patient's right eye (od) on (b)(6) 2014.That evening after surgery the patient had headache and vomiting, suggestive of increased intraocular pressure.The patient has also complained of glare.At the last post-op visit, the patient's symptoms have subsided but intraocular pressure was 24.The lens remains implanted.The patient's post-op best-corrected visual acuity was 20/20.
 
Manufacturer Narrative
This product is manufactured in the u.S.But not marketed in the u.S.(b)(4) - intraocular pressure rise; vomiting; headache; (glare).Device evaluated by manufacturer? no.Lens implanted.Evaluation method: work order search.Results: a lens work order search was performed and no similar complaints were found within the work order.Conclusions - (no conclusion can be drawn): based on the complaint history and work order search, a specific root cause of the event could not be determined.(b)(4).
 
Manufacturer Narrative
Event problem and evaluation codes: method: (process evaluation): device history record review.Results: (evaluation result): a review of the device history record was performed and nothing was found in the manufacturing, sterilization and packaging processes of this lens that was likely to have contributed to the complaint.No root cause for the complaint was determined.Conclusion: (unable to confirm complaint): based on the complaint history, work order search and the device history record review, a specific root cause of the event could not be determined.(b)(4).
 
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Brand Name
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
Type of Device
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
althea watson
1911 walker avenue
monrovia, CA 91016
6263037902
MDR Report Key4542564
MDR Text Key18893425
Report Number2023826-2015-00176
Device Sequence Number1
Product Code MTA
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Distributor,distributor,forei
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/29/2015
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 Physician
Device Expiration Date01/31/2017
Device Model NumberVICMO12.1
Other Device ID NumberDIOPTER -07.50
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 01/29/2015
Initial Date FDA Received02/24/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/17/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CARTRIDGE MODEL AND LOT NUMBER UNK
Patient Age22 YR
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