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

Model Number VTICMO13.2

Device Problems Off-Label Use (1494); Device Dislodged or Dislocated (2923)

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

Event Date 06/18/2023

Event Type  Injury  

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).

Event Description

The reporter indicated that a 13.2mm, vticmo13.2, -10.0/3.5/095 (sphere/cylinder/axis), implantable collamer lens was implanted into the patient's right eye (od) on (b)(6) 2023.The lens was repositioned on 18/aug/2023 due to lens rotation not associated to a low vault.This did not resolve the problem.On 18/aug/2023 the lens was exchanged for a same length lens, this resolved the problem.Cause of the event is reported as unknown.

Manufacturer Narrative

H6 - medical device problem code 1494: off-label use (under 21 yrs of age at date of implantation) added to initial mdr.Claim # (b)(4).

Manufacturer Narrative

H3: device evaluation: the lens was returned dry in a microcentrifuge vial.Visual inspection found no visible damage to the lens.Dimensional inspection found the lens to be within specification.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: 18301998
• MDR Text Key: 330176704
• Report Number: 2023826-2023-05512
• Device Sequence Number: 1
• Product Code: QBC
• 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,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2023
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 18 YR
• Patient Sex: Male