MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; INTRAOCULAR LENS

Model Number VICMO13.2

Device Problems Misfocusing (1401); Improper or Incorrect Procedure or Method (2017)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

Product manufactured but not sold in the u.S.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -17.5 diopter, into the patient's right eye (od) on (b)(6) 2020.Reportedly, the lens was exchanged on (b)(6) 2020 with a same size and model, different diopter lens due to refractive surprise.The problem was resolved.The cause of the event is reported as user error; calculations were performed incorrectly by the user.

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, ca ; 3037902146
• MDR Report Key: 10048973
• MDR Text Key: 190690674
• Report Number: 2023826-2020-01038
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2020

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 Expiration Date: 11/30/2022
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2020
• Initial Date FDA Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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: 24 YR