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

Model Number VTICM5 13.2

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 09/30/2021

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm vticm5 13.2 implantable collamer lens of -10.5/2.5/177 (sphere/cylinder/axis) was implanted into the patient's left eye (os) on (b)(6) 2021.On (b)(6) 2021 the lens was exchanged for a shorter length lens due to toxic anterior segment syndrome (tass).Diagnostic performed: intense inflammation within the anterior chamber.Treatment performed: antimicrobial treatment and anti-inflammatory treatment were given.The replacement lens resolved the problem.Reporter states "it is difficult to determine the cause.

Manufacturer Narrative

Weight - race:unk.Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.Lens work order search- no similar complaint event(s) within associated lots were found.Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work orders(s), including the suspected device, have been manufactured within established parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.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 ; 6263037902
• MDR Report Key: 13958873
• MDR Text Key: 288276032
• Report Number: 2023826-2022-00953
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/07/2022

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: 03/31/2023
• 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: 03/07/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2020
• 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#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 26 YR
• Patient Sex: Female