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

Model Number VTICM5_12.6

Device Problem Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that a vial with a 12.6mm, vticm5_12.6, -9.0/1.5/069 (sphere/cylinder/axis), implantable collamer lens had whiteish powder on the vial and the lens was implanted into the patient's eye.The lens remains implanted.Additional information has been requested but none has been forthcoming.

• 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 JAPAN INC.; 1-1-1 nishi shimbashi; minato-ku, 105-0 003; JA 105-0003
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 18979472
• MDR Text Key: 338612868
• Report Number: 2023826-2024-01237
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311308088
• UDI-Public: 00840311308088
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2024
• Initial Date FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2023
• 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