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

Model Number VTICM5 12.6

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Toxic Anterior Segment Syndrome (TASS) (4469)

Event Date 10/05/2022

Event Type  Injury  

Event Description

The reporter stated that a 12.6mm vticm5 12.6 implantable collamer lens of -10.00/3.0/082 (sphere/cylinder/axis) was implanted into the patient's left eye (os) (b)(6) 2022.Toxic anterior segment syndrome (tass) was reported.The lens remains implanted.Steroid eye drops and oral medication were prescribed.Reporter states the problem has not resolved and patient outcome status is unknown.Cause reported as device.

Manufacturer Narrative

(b)(4).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: 15765127
• MDR Text Key: 303392915
• Report Number: 2023826-2022-03999
• Device Sequence Number: 1
• Product Code: QCB
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

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 Model Number: VTICM5 12.6
• 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: 10/13/2022
• Initial Date FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• 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-ACCUJET, LOT#-UNK; INJECTOR MODEL-ACCUJET, LOT#-UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR
• Patient Sex: Female