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

Model Number VTICM5_13.7

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problems Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/13/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's eye.The surgeon reports the patient had excessive vaulting; elevated intraocular pressure and angle closer; it was later additionally noted the patient pressures were stable on medication and angles narrow.Lens remains implanted.

Manufacturer Narrative

Additional information: h6: investigation type code: 4110- lens work order search-no similar complaint event(s) within associated lots were found.B5: "the surgeon implanted a 13.7mm vticm5_13.7 implantable collamer lens of diopter -10.50/1.0/104 (sphere/cylinder/axis) into the patient's right eye (od) on (b)(6) 2022.The patient experienced an excessive vault; angle closure with elevated iop and medication was prescribed.On (b)(6) 2023, the lens was exchanged for the same model/shorter length lens and the problem was resolved.The status of the eye was reported as "initially some corneal odema and endothelial cell loss due to tricky exchange (constriction of pupil during procedure) will complete another complaint form but vision excellent." the reporter indicated the cause of the event was a patient related factor." corrected data: g2: other: "united kingdom" should be corrected to "ireland".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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 16127557
• MDR Text Key: 306981979
• Report Number: 2023826-2023-00115
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: VTICM5_13.7
• 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: 12/13/2022
• Initial Date FDA Received: 01/09/2023
• Supplement Dates Manufacturer Received: 02/20/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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: 25 YR
• Patient Sex: Female