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

Model Number VTICM5_13.2

Device Problems Misfocusing (1401); Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Uveitis (2122); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/10/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2; -1.50/+3.5/078 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6)2022.The surgeon reports uveitis after surgery without previous history; deposits in icl that decrease visual acuity; patient is treated with corticosteroids; and there is pigment dispersion.Lens remains implanted.The cause of the event was reported as unknown; and device did not fail to perform as intended.

Manufacturer Narrative

Corrected data: h6: medical device problem code-1494 should be added for correction.Off-label usage.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).

Manufacturer Narrative

Additional information: b5: on an unknown date the lens was removed due to transient loss of bcva, and blurred vision.Refractive treatment was performed.The lens was replaced with a smaller lens.Reportedly, "normal, without signs and symptoms".Additional information "at first we replaced icl to check if deposits improved, but finally we have to explant it and we do a refractive treatment".Problem not resolved.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16010278
• MDR Text Key: 305776899
• Report Number: 2023826-2022-04648
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup,Followup
• Report Date: 11/21/2022

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 Expiration Date: 04/30/2023
• 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: 11/21/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/25/2023; 02/16/2023; 02/08/2024
• Supplement Dates FDA Received: 01/26/2023; 02/16/2023; 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• 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#-1583674.; FOAM TIP PLUNGER MODEL-FTP, LOT#-1577165.
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Male