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

Model Number VTICM5_12.6

Device Problem Misfocusing (1401)

Patient Problems Conjunctivitis (1784); Corneal Edema (1791); Intraocular Pressure Increased (1937); Pain (1994); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/17/2022

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.Claim# (b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6mm vticm5_12.6; -10.00/+2.50/91 (sphere/cylinder/axis) implantable collamer lens into the patient's right eye (od) on (b)(6) 2022.The patient intraocular pressure increased and complained of blurry vision and pain on the day of surgery; medication was prescribed and the surgeon performed irrigation before sending her home.One day post op the patient had high iop and corneal edema centrally with conjunctival redness.Pupillary block 3+ cells/flares noted.On this day the surgeon reported noticing a thin membrane over the central hole of the icl; which they performed an additional irrigation with additional medication prescribed.It was indicated after another postop visit surgeon performed an additional irrigation and the membrane washed out during this and the patient's iop became stable.It was further indicated 1 week postop the iop is stable; no corneal edema but patient has pupil mid-dilated due to the pupillary block and 1.2 ct vaulting.The patient will continue being monitored.Cause of the event was reported as the device.

• 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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 13698235
• MDR Text Key: 287027615
• Report Number: 2023826-2022-00761
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• 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
• Report Date: 02/07/2022

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_12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2022
• Initial Date FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female