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

Model Number VTICMO13.2

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

Patient Problem Hyphema (1911)

Event Date 04/18/2023

Event Type  Injury  

Event Description

The reporter indicated that a 13.2mm, vticmo 13.2, -9.5/1.0/011 (sphere/cylinder/axis), implantable collamer lens was implanted vertically into the patient's right eye (od) on (b)(6) 2023.Hyphema was observed.Irrigation was performed.This did not resolve the problem.The lens was explanted on (b)(6) 2023.This resolved the problem.Cause of the event is reported as unknown.

Manufacturer Narrative

A4 - unk, a5 - unk, a6 - unk.H6 - work order search: no similar complaint type events were reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

Corrected data: h6-health impact code: "4625- anterior chamber irrigation" should be added.B5- the reporter indicated that the surgeon vertically implanted a 13.2mm vticmo 13.2 implantable collamer lens of diopter -9.5/+1.0/11 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced hyphaema.Anterior chamber irrigation was performed but that did not resolve the problem.Reportedly "irrigated the hyphema, and there were no additional interventions.The cause of the bleeding was couldn't be determined, so the icl lens were removed".On (b)(6) 2023 the lens was explanted and the problem was resolved.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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17216366
• MDR Text Key: 318009262
• Report Number: 2023826-2023-02429
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 06/05/2023

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: VTICMO13.2
• 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: 06/05/2023
• Initial Date FDA Received: 06/28/2023
• Supplement Dates Manufacturer Received: 09/06/2023
• Supplement Dates FDA Received: 09/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2022
• 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.; FOAMTIPPLUNGER MODEL#FTP,LOT#UNK.; INJECTOR MODEL#MSI-PF,LOT#UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female