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

Model Number TMICL13.2

Device Problems Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problems Corneal Edema (1791); Headache (1880); Blurred Vision (2137); Eye Pain (4467)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2; -12.5/+1.00/179 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6)2023.The patient experienced lens rotation, the surgeon also noted headaches, corneal edema, blurry vision and glares.Lens remains implanted.The cause of the event was reported as user error - preop axis was not accurate based on the topography and auto-refract axis of about 49 degrees and it was a pre-op measurement error not an issue with the lens itself.

Manufacturer Narrative

B5 - it was also reported that the patient had eye pain and medication was used, timolol and diamox.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 SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 17935878
• MDR Text Key: 326142233
• Report Number: 2023826-2023-04537
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542116923
• UDI-Public: 00841542116923
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

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?: Yes
• Device Operator: Health Professional
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 12/26/2023
• Supplement Dates FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR
• Patient Sex: Female