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

Model Number VTICM5_12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 01/19/2024

Event Type  Injury  

Manufacturer Narrative

H6 - type of investigation: 4110 - lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -4.5/1.0/109 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2024.The surgeon reports the patient has tass which was noticed on (b)(6) 2024, diagnostics was performed, and steroids were used.Lens remains implanted with a planned replacement.Cause of the event was reported as the device but noted the device did not fail to perform as intended.

Manufacturer Narrative

It was later reported that on (b)(6) 2024 the lens was explanted but the problem was not resolved.The cause of the event is now reported as unknown.The surgeon additionally noted "currently in good condition, plans to reoperate after futher observation.Postoperative 1w deposts on lens and cornea, 2w kp pig (+) with complaint of blurrying, 3w with complaints of blurring.Subsequently patient infected with covid 19 and the lens was removed.Claim#: (b)(4).

Manufacturer Narrative

H6 - type of investigation 3331 - device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker ave; monrovia, CA 91016
• MDR Report Key: 18946963
• MDR Text Key: 338185024
• Report Number: 2023826-2024-01329
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00840311307715
• UDI-Public: 00840311307715
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/20/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 03/28/2024
• Date Device Manufactured: 08/31/2023
• 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.; FOAM TIP PLUNGER - LOT#UNK.; INJECTOR MODEL: MSI-PF - LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female