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

Model Number VTICM5 12.1

Device Problem Misfocusing (1401)

Patient Problems Inflammation (1932); Red Eye(s) (2038)

Event Type  Injury  

Manufacturer Narrative

H6-health impact:4644- oral steroid and topical steroid eye drops.H6-investigation type 4110: lens work order search- no similar complaint event(s) within associated lots were found.Claim # (b)(4).

Event Description

The reporter indicated that a 12.1mm vicm5 12.1 implantable collamer lens of -12.50/2.5/179 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6) 2023.Pigment dispersion and anterior chamber inflammation was observed.Oral steroids and topical steroids were used to reduce the inflammation.On (b)(6) 2023 the lens was explanted and the problem was resolved.Cause reported as unknown.

Manufacturer Narrative

B5: the reporter indicated that a 12.1mm vticm5 12.1 implantable collamer lens of -12.50/2.5/179 (sphere/cylinder/axis) was implanted into the patients left eye (os) on (b)(6)2023.Pigment dispersion and anterior chamber inflammation was observed.Oral steroids and topical steroids were used to reduce the inflammation.On (b)(6) 2023, the lens was explanted and the problem was resolved.Cause 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: 18017491
• MDR Text Key: 326674928
• Report Number: 2023826-2023-04788
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/14/2023

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 12.1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/27/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/14/2023
• Date Device Manufactured: 01/03/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male