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

Model Number VTICM5_13.2

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/18/2023

Event Type  Injury  

Event Description

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

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.Excessive vault, angle closure with elevated iop(62mmhg), unreactive (fixed) pupil, blurred vision, and corneal edema.Lens remains implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

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

Manufacturer Narrative

Corrected data: b5 - the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -8.0/1.0/090 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6)2023.The patient experienced excessive vaulting, elevated intraocular pressure, angle closure, unreactive fixed pupil, corneal edema causing blurred vision.Iop was normalized and fixed dilated pupil minimally reactive to pilocarpine.The problem is not resolved.The cause of the event was reported as 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: 18473796
• MDR Text Key: 332381317
• Report Number: 2023826-2024-00131
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311311149
• UDI-Public: 00840311311149
• 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; 04/06/2024
• Supplement Dates FDA Received: 01/12/2024; 04/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• 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#LIOLI-24,LOT#UNK
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 36 YR
• Patient Sex: Male