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

Model Number VICH 13.2

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Intraocular Pressure Increased (1937); Pupillary Block (2026); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm vich 13.2, +05.00 diopter, implantable collamer lens, into the patient's right eye (od) on (b)(6) 2018.Significant reduction of irido-corneal angles and elevated iop was observed.An addition of new pi was performed.This resolved the problem.Cause of the event is reported as user error.Reportedly, "with quick action and pi, iop resolved without any loss of vision.".

Manufacturer Narrative

B4 - corrected to (b)(6) 2020 in initial mdr.B5 - "pupillary block was also reported." should be added to initial mdr.G3 - corrected to (b)(6) 2020 in initial mdr.H6 - health effect clinical code 2026 should be added to initial mdr.Claim# (b)(4).

Manufacturer Narrative

H1 - corrected to serious injury in initial mdr.H6 - health effect clinical code 4581: code not available - significant reduction of iridocorneal angles.H6 - health effect impact code 4625: additional surgery - addition of pi.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia, ca
• MDR Report Key: 10138819
• MDR Text Key: 194811060
• Report Number: 2023826-2020-01222
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 05/14/2020

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: 06/30/2021
• Device Model Number: VICH 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 12/04/2020; 12/23/2020
• Supplement Dates FDA Received: 12/05/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 YR