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

Model Number VTICM5_12.1

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicted that a 12.1mm, vticm5_12.1, -12.00/1.50/82 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2017.On (b)(6) 2019 the lens was exchanged for a non toric lens due to lens rotation not associated to a low vault.This exchange resolved the problem.

Manufacturer Narrative

Device evaluation: lens was returned in a micro-centrifuge vial, dry with clear surgical residue/debris on the lens.Visual inspection found no visible damage to the lens and residue and debris on the lens.Device code 1494: off-label use (under 21yrs of age at date of implant) 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: 9533576
• MDR Text Key: 173251989
• Report Number: 2023826-2019-02491
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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: 07/31/2020
• Device Model Number: VTICM5_12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR