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

Model Number VTICH13.2

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

Patient Problems Intraocular Pressure Increased (1937); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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, +5.00/+2.0/162 (sphere/cylinder/axis) in the patients right eye (od).The lens was reported as having excessive vaulting and iridocorneal touch.The lens remained implanted.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

Additional data: b5: the reporter indicated the patient has intermittent angle closure and is stable on pilocarpine.H6: health impact- clinical code: 4581 - angle closure.Claim # (b)(4).

Manufacturer Narrative

Corrected data: h6 - work order search results and information should be removed as it is no longer applicable to this claim.H6 - 213 and 4310 codes added due to previous product evaluation results.Claim#: (b)(4).

Manufacturer Narrative

Additional data: b5: the reporter indicated the surgeon implanted a 13.2mm vtich13.2 implantable collamer lens,+5.00/+2.0/162 (sphere/cylinder/axis), in the patient's right eye (od) on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to excessive vaulting, angle closure, with elevated intraocular pressure (iop) and iridocorneal touch.The lens was exchanged for a shorter lens.The vault much improved, angle open, iop normal, corneal edema, which caused a reduction in vision.At final assessment, the vault was satisfactory and vision was good.The issue was resolved and patient has a good outcome.H3: device evaluation: the lens was returned in liquid, in a vial.Visual inspection found no visible damage to the lens.Dimensional verification was performed and the lens was found to be in specification.H6 - device code: 1494 - this lens model is contraindicated for patients with an anterior chamber depth (acd) less than 3.0mm.H6 - device code: 1494 - this lens model is contraindicated for patients with a pre-existing condition - keratoconus.Claim # (b)(4).

Manufacturer Narrative

B5: the reporter indicated the surgeon implanted a 13.2mm vtich13.2 implantable collamer lens, +4.50/+2.0/165 (sphere/cylinder/axis), in the patient's right eye (od) on (b)(6) 2020.The lens was explanted on (b)(6) 2020, due to excessive vaulting, angle closure, with elevated intraocular pressure (iop) and iridocorneal touch.The patient was administered pilocarpine and was stable.The lens was exchanged for a shorter lens.The vault much improved, angle open, iop normal, corneal edema, which caused a reduction in vision.At final assessment, the vault was satisfactory and vision was good.The issue was resolved and patient has a good outcome.Claim # 717114.

• 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: 10498204
• MDR Text Key: 205905906
• Report Number: 2023826-2020-01979
• 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: 09/30/2021
• Device Model Number: VTICH13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/06/2020
• Supplement Dates Manufacturer Received: 10/23/2020; 12/11/2020; 04/19/2021; 05/13/2021
• Supplement Dates FDA Received: 11/22/2020; 04/23/2021; 05/05/2021; 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.; UNK.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29 YR