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

Model Number VTICMO12.6

Device Problem No Apparent Adverse Event (3189)

Patient Problems Retinal Detachment (2047); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Race: unk.Ethnicity: unk.Explant date: unk.Gma/510k: this product is manufactured in the u.S.But not marketed in the u.S.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -16.50/+1.5/123 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2021.The reporter indicated the refraction was not stable and the lens remained implanted.This was the replacement lens for mfr.Report # 2023826-2021-02786.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

Weight: unk.Race: unk.Ethnicity: unk.Explant date: unk.Gma/510k: this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -16.50/+1.5/123 (sphere/cylinder/axis) into the patients right eye (od) on (b)(6) 2021.The reporter indicated the refraction was not stable and the lens remained implanted.This was the replacement lens for mfr.Report # 2023826-2021-02786.Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5: the cause of the reported postoperative unstable refraction was due to a retinal detachment which will be treated at the moment.The retinal detachment was not caused by the evo visian icl.It seemed to be caused by the further high myopia of the patient eye.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: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 13502410
• MDR Text Key: 285958964
• Report Number: 2023826-2022-00410
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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
• Report Date: 01/11/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/09/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2021
• 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
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female