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

Model Number VICM512.6

Device Problem No Apparent Adverse Event (3189)

Patient Problems Corneal Edema (1791); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

A4-a6:unk.H6: work order search: no similar complaints within associated lots were found.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vicm512.6 implantable collamer lens of a -9.0 was implanted as a replacement lens into the patient's left eye (os) on (b)(6) 2023.Mild edema was reported.

Manufacturer Narrative

B5: the problem was resolved.Claim# (b)(4).

Manufacturer Narrative

It was later reported "eye is quiet and no edema.Pt vision is 6/6".Claim# (b)(4).

Manufacturer Narrative

Corrected data: h6-health effect- clinical code: "1791" should be added.B5- the reporter indicated that the surgeon implanted a 12.6mm vicm5_12.6 implantable collamer lens of diopter -9.00 into the patient's left eye (os) on (b)(6) 2023 as a replacement lens.The patient experienced a mild edema.The lens remains implanted and the problem was resolved.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 800 royal oaks dr. suite: 210; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 18504002
• MDR Text Key: 332797584
• Report Number: 2023826-2024-00204
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00840311300587
• UDI-Public: 00840311300587
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup,Followup,Followup
• Report Date: 01/02/2024

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: VICM512.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/02/2024
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/16/2024; 01/15/2024; 02/19/2024
• Supplement Dates FDA Received: 01/16/2024; 01/23/2024; 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2023
• 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
• Treatment: UNK.
• Patient Sex: Male