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

Model Number VTICH12.6

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problems Headache (1880); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim#: (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vtich12.6; 4/3.5/79 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The surgeon reports there was low vaulting with lens rotation, blurred vision, headaches, the lens was repositioned but this did not resolve the problem.The lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

• 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
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18086711
• MDR Text Key: 327557894
• Report Number: 2023826-2023-05009
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2023

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 Model Number: VTICH12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK.; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male