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

Model Number VTICM5 12.1

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583); Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2022

Event Type  malfunction  

Event Description

The reporter indicated that a 12.1mm vticmo 12.1 implantable collamer lens of -5.00/1.5/079 (sphere/cylinder/axis) was implanted into the patients right eye (od) on an unknown date.On (b)(6) 2022 the lens was exchanged for a longer length lens for an unknown reason.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

B5-the reporter indicated that a 12.1mm vticm5 12.1 implantable collamer lens of -5.0/1.5/079 (sphere/cylinder/axis) was implanted into the patients right eye (od) on (b)(6) 2022.On (b)(6) 2022 the lens was implanted; removed and exchanged intra-operatively for a longer length lens due to low vault.The replacement lens resolved the problem.Cause reported as user error."a wrong sized lens was ordered." h6-device code 1494: off-label use (acd < 3.0mm).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: 15795262
• MDR Text Key: 303626091
• Report Number: 2023826-2022-04003
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/16/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICM5 12.1
• 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: 10/16/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2021
• 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: INJECTOR MODEL: MSI-PF, LOT# UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 1 MO
• Patient Sex: Male