MAUDE Adverse Event Report: STAAR SURGICAL COMPANY PHAKIC INTRAOCULAR LENS

Model Number MICL13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017); Optical Problem (3001); No Apparent Adverse Event (3189)

Patient Problems Visual Disturbances (2140); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

Product code: unk; esubmitter software does not allow for unk or blank entry.(b)(4).

Event Description

The reporter indicated that the surgeon implanted an implantable collamer lens into the patient's right (od) eye.The surgeon reportedly is considering exchanging the lens.Attempts to obtain additional information have not been successful.

Event Description

The reporter indicated that the surgeon implanted a 13.2mm micl13.2 implantable collamer lens into the patient's right (od) eye on (b)(6) 2020.On (b)(6) 2020 the lens was exchanged with a shorter lens due to excessive vault and glare/halos.The problem was resolved.The cause is reported as user error-the surgeon remeasured the wtw value.

Manufacturer Narrative

B5-please disregard previous b5 statement.H6-clinical code corrected.Impact code corrected.Device code corrected.Claim# (b)(4).

• Brand Name: PHAKIC INTRAOCULAR LENS
• Type of Device: UNK
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10930514
• MDR Text Key: 219156376
• Report Number: 2023826-2020-02826
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/01/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention