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

Model Number VTICMO13.2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Optical Problem (3001)

Patient Problems Visual Disturbances (2140); Halo (2227)

Event Date 01/02/2024

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm0 13.2, -14.5/2.0/074 (sphere/cylinder/axis), implantable collamer lens into the patient's left eye (os).Glare/haloes was observed.Lens remains implanted.Patient remains under observation.Cause of the event is reported as unknown.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

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

Manufacturer Narrative

Additonal data: h6-health effect - impact code (f): "2199" should be removed and "4627" should be added.H6- medical device problem code (a): "2993" should be added.B5- the reporter indicated that the surgeon implanted a 13.2mm vticmo 13.2 implantable collamer lens of diopter -14.5/+2.0/074 (sphere/cylinder/axis) into the patients left eye (os) on (b)(6)2023.The patient experienced glares/haloes.On (b)(6) 2024 the lens was explanted and the problem was resolved.Additional information provided: "patient is happy".The reporter indicated the cause of the event is unknown.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
• 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: 18701829
• MDR Text Key: 336432766
• Report Number: 2023826-2024-00605
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICMO13.2
• 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: 01/26/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/06/2023
• 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: CARTRIDGE MODEL#SFC-45, LOT#UNK.; FOAMTIPPLUNGER MODEL#FTP, LOT#UNK.; INJECTOR MODEL#MSI-PF, LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Male