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

Model Number VTICM5 13.2

Device Problems Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  Injury  

Manufacturer Narrative

Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted an implanted collamer lens into the patient's eye on (b)(6) 2023.It was indicated that the lens was displaced through the pupil.Lens remains implanted.Attempts to obtain additional information have not been successful.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: h6: health effect- clinical code: 4581- "iris atrophy." b5: the reporter indicated that the surgeon implanted a 13.2mm vticm5_13.2 implantable collamer lens of diopter -9.50/3.0/141 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2023.The patient experienced lens dislocation and iris atrophy.Reportedly "half of the lens displaced through the pupil" and "planning to reposition".The lens was repositioned and this resolved the problem.Status of the eye: "back to normal".The cause of the event: patient related factor - "patient inadvertently rubbed eye".Claim#: (b)(4).

Manufacturer Narrative

Corrected data: h6-health effect- impact code: "4628" should be added.H6- type of investigation code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC 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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16873135
• MDR Text Key: 314639714
• Report Number: 2023826-2023-01664
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542116541
• UDI-Public: 00841542116541
• 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,Followup
• Report Date: 04/12/2023

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: VTICM5 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/04/2023
• Supplement Dates Manufacturer Received: 05/23/2023; 06/14/2023
• Supplement Dates FDA Received: 05/23/2023; 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 26 YR
• Patient Sex: Male