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

Model Number VTICM5_13.2

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

Patient Problems Macular Edema (1822); Inflammation (1932); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2021

Event Type  Injury  

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens, -9.5/+1.0/090 (sphere/ cylinder/ axis) into the patient's right eye (od) on (b)(6) 2021.On (b)(6) 2021 the lens was explanted due to pigment dispersion and ac inflammation with cme.Reportedly the problem is resolved.

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).No similar complaints reported for units within the same lot.Claim # (b)(4).

Manufacturer Narrative

B5-additional information: reportedly the patient was treated with oral and topical steroids.No infection occurred and the cause of the event is 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 12973341
• MDR Text Key: 284909425
• Report Number: 2023826-2021-04714
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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: 02/29/2024
• 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: 11/17/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/10/2021
• Supplement Dates FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2021
• 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 MODEL-FTP, LOT # UNK; INJECTOR MODEL-MSI-PF, LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female