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U.S. Department of Health and Human Services

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

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STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS (ICL); PHAKIC TORIC INTRAOCULAR LENS Back to Search Results
Model Number VTICM5_13.2
Device Problems Misfocusing (1401); Device Dislodged or Dislocated (2923)
Patient Problems Blurred Vision (2137); No Code Available (3191)
Event Date 11/23/2018
Event Type  Injury  
Manufacturer Narrative
This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).Work order search: no similar complaint was reported for units within the same lot.(b)(4).
 
Event Description
The reporter indicated the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -0.50/+6.0/100 (sphere/cylinder/axis), in the patient's right eye (od), on (b)(6) 2018.The reporter indicated the patient experienced a refractive surprise.The lens was repositioned and the problem was resolved.The lens remains implanted.The reporter indicated the cause of the event was due to patient related factor.
 
Manufacturer Narrative
The reporter indicated the patient had decided not to have a lvc procedure to correct current refractive error after ticl implantation.The plan is to explant the lens.(b)(4).Claim#: (b)(4).
 
Manufacturer Narrative
Additional data: b5-the reporter indicated the "lens was not stable" on (b)(6) 2019.On (b)(6) 2019 the reporter stated, "the surgeon tried to correct the refractive surprise with a repositioning of both lenses.For this he rotated the misaligned ticls to he axis of the iods.After that (1day postop) first the refractions were good and everything was fine.At the next examination mid of january the ticls have rotated again to the same misaligned axis as before.In this position the lenses were now stable and so the surgeon decided to make a laser touch up to correct the residual refraction on both eyes".Patient code: 3191 secondary surgical intervention, laser touch up.Claim# (b)(4).
 
Manufacturer Narrative
Device code: "2923" not included in the supplemental mdr#2.Claim# (b)(4).
 
Manufacturer Narrative
The reporter indicated the lens was explanted on (b)(6) 2019.Because of strong bleeding after removing the lens out of the sulcus, the surgeon decided to wait to implant the exchange lens for a couple of months.The patient and eye are fine.H6 - patient code: 3191 - secondary surgical intervention, lens explanted, strong bleeding corrected data: d2: phakic toric intraocular lens, product code: qcb claim #(b)(4).
 
Manufacturer Narrative
H3: device evaluation: the lens was returned dry, in lens case/vial.Visual inspection found the lens optic and haptic broken.Dimensional verification was performed and the lens was found to be in specification.Claim # (b)(4).
 
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Brand Name
IMPLANTABLE COLLAMER LENS (ICL)
Type of Device
PHAKIC TORIC INTRAOCULAR LENS
Manufacturer (Section D)
STAAR SURGICAL COMPANY
1911 walker avenue
monrovia CA 91016
MDR Report Key8182336
MDR Text Key130972306
Report Number2023826-2018-01886
Device Sequence Number1
Product Code QCB
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/26/2018
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 Date03/31/2021
Device Model NumberVTICM5_13.2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2020
Initial Date Manufacturer Received 11/26/2018
Initial Date FDA Received12/19/2018
Supplement Dates Manufacturer Received02/25/2019
03/18/2019
06/05/2019
12/18/2019
03/09/2020
Supplement Dates FDA Received03/06/2019
03/19/2019
07/03/2019
01/17/2020
04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
Patient Outcome(s) Required Intervention;
Patient Age24 YR
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