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

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).

• 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 Key: 8182336
• MDR Text Key: 130972306
• Report Number: 2023826-2018-01886
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• 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 Date: 03/31/2021
• Device Model Number: VTICM5_13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 11/26/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 02/25/2019; 03/18/2019; 06/05/2019; 12/18/2019; 03/09/2020
• Supplement Dates FDA Received: 03/06/2019; 03/19/2019; 07/03/2019; 01/17/2020; 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• 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 Age: 24 YR