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

Model Number VTICMO12.6

Device Problems Off-Label Use (1494); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/14/2022

Event Type  Injury  

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -08.00/+1.0/161 (sphere/cylinder/axis) into the patient's left eye (os) on (b)(6) 2022.The patient was complaining of pain, poor ability to read and low vault was reported.The lens remains implanted.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

(b)(4).Lens work order search: no similar complaints reported for units within the same lot.Claim# (b)(4).

Manufacturer Narrative

Claim# (b)(4).

Manufacturer Narrative

B5 - the lens was explanted on (b)(6) 2022 and problem resolved.Reportedly, "icl has been explanted, patient goes back to using refractive appliances.Cause of event is reported as unknown.Claim# (b)(4).

Manufacturer Narrative

H3: device evaluation - lens was returned in vial in liquid.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 enriquez ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 14639450
• MDR Text Key: 294669844
• Report Number: 2023826-2022-01795
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/06/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: VTICMO12.6
• 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: 05/09/2022
• Initial Date FDA Received: 06/08/2022
• Supplement Dates Manufacturer Received: 08/04/2022; 09/06/2022; 11/14/2022
• Supplement Dates FDA Received: 08/08/2022; 10/04/2022; 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female