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

Model Number VTICM5_13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); No Apparent Adverse Event (3189)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

A1 - unk a2 - unk a3 - unk a4 - unk a5 - unk a6 - unk b3 - unk d2 - product code: unk (esubmitter software does not allow for a blank or 'unk' entry) d4 - unk d6a - unk h4 - unk claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's eye.Elevated iop and corneal edema was observed.Lens remains implanted.Additional information has been requested but none has been forthcoming.

Event Description

The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's eye.Excessive vault was observed.Lens remains implanted.Reportedly, patient doing well.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Additional information: entered within form.Claim# (b)(4).

Manufacturer Narrative

Corrected data: b1: adverse event should be corrected to product problem.B5: elevated iop and corneal edema should be omitted for correction.H1: serious injury should be corrected to malfunction.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: 18473806
• MDR Text Key: 332380341
• Report Number: 2023826-2024-00132
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311311125
• UDI-Public: 00840311311125
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/21/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICM5_13.2
• 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: 12/21/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/10/2024; 04/05/2024
• Supplement Dates FDA Received: 01/12/2024; 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2023
• 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#LIOLI-24,LOT#UNK.; UNK.
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Male