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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dry Eye(s) (1814); Intraocular Pressure Increased (1937); Eye Pain (4467)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

(b)(6) complaint: the reporter indicated that the surgeon implanted an implantable collamer lens (icl) into the patient's eye.The patient reports elevated iop and painful dry eye.Attempts to obtain additional information have not been successful.

Manufacturer Narrative

On (b)(6) 2020, it was determined that the current case is a duplicate of mfr report# 2023826-2019-00730.Please disregard the current report.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: UNK
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10936812
• MDR Text Key: 219332575
• Report Number: 2023826-2020-02828
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 12/09/2020
• Supplement Dates FDA Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other