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 Fatigue (1849); Headache (1880); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/28/2023

Event Type  Injury  

Manufacturer Narrative

Health effect clinical code: 4581 hyperopic/showing cyl.Type of investigation: 4110 lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -6.5/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6) 2023.The surgeon reports the patient is hyperopic and showing residual cyl; has headaches and fatigue; steroids were prescribed.Lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: b5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -6.5/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The surgeon reports the patient is hyperopic and showing residual cyl; has headaches and fatigue; steroids were prescribed.Reportedly, the lens was exchanged on (b)(6) 2023 for a same model and same length but different diopter lens.It has not been reported if the problem resolved.Claim# (b)(4).

Manufacturer Narrative

Corrected data: d6a: should be corrected to 09-feb-2023.H6: 4629 should be corrected to 4627.Additional information: b5: the reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -6.5/2.5/102 (sphere/cylinder/axis) implantable collamer lens into the patient's left eye (os) on (b)(6)2023.The surgeon reports the patient is hyperopic and showing residual cyl; has headaches and fatigue; steroids were prescribed.Reportedly, the lens was exchanged on (b)(6) 2023 for a same model and same length but different diopter lens.It is unclear whether lens removal and replacement occurred intraoperatively.Residual cylinder was present after the exchange.It has not been reported if the problem resolved.Claim# (b)(4).

Manufacturer Narrative

Additional information: d9: return date: 25-aug-2023.H3 - device evaluation: the lens was returned in liquid in a vial.Visual inspection found the lens haptic torn and fiber on the lens.Dimensional and functional inspection found the lens to be within specifications.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16622823
• MDR Text Key: 312109882
• Report Number: 2023826-2023-01088
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542114509
• UDI-Public: 00841542114509
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/28/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 05/26/2023; 06/27/2023; 01/08/2024
• Supplement Dates FDA Received: 06/22/2023; 07/13/2023; 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2022
• 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#-1589913.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1590141.; INJECTOR MODEL-MSI-PF, LOT#-UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female