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

Model Number VTICH13.2

Device Problems Misfocusing (1401); Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Blurred Vision (2137); No Code Available (3191)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vtich13.2 implantable collamer lens, +6.00/+1.5/032 (sphere/cylinder/axis) in the patients left eye (os) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to excessive vaulting, angle closure with elevated intraocular pressure.The lens was exchanged for a shorter lens but the problem was not resolved.The vault was much improved, the angle was open and iop was normal.There was corneal edema, which was causing reduction of vision.See mfr report # 2023826-2020-02050 for replacement lens.

Manufacturer Narrative

H3 - device evaluation: lens was returned in a micro-centrifuge vial with moisture and residue on the lens.Visual inspection found the lens optic and haptic torn with residue on the lens.Claim#: (b)(4).

Manufacturer Narrative

Corrected data: h6 - patient code: 1791 and 2137 should be removed as it is not applicable.H6 - device code: 1401 should be removed as it is not applicable.Claim#: (b)(4).

Manufacturer Narrative

Corrected data: h6 - work order search results and information should be removed as it's not applicable for this claim.Claim#: (b)(4).

Manufacturer Narrative

Additional information: b5 - lens sphere/cylinder/axis should be changed to +5.00/1.5/049.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
• MDR Report Key: 10498203
• MDR Text Key: 206103947
• Report Number: 2023826-2020-01980
• 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: 08/07/2020

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 Date: 02/28/2022
• Device Model Number: VTICH13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/06/2020
• Supplement Dates Manufacturer Received: 12/05/2020; 03/23/2021; 04/19/2021; 05/13/2021
• Supplement Dates FDA Received: 12/13/2020; 03/25/2021; 04/20/2021; 05/13/2021
• 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 AND LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR