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

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

A4-a6:unk; b3: unk; d4 (experiation date); unk no serial number reported.; d6a: unk; h4 (device manufacturing date): no serial number reported.; h6: user error; claim# (b)(4).

Event Description

The reporter indicated that an implantable collamer lens was implanted into the patient's eye.Reportedly, "remove/replace both eyes of the same patient.Backup lenses were implanted," and "sounds like she didn't load the lens correctly, resulting in the lens inserting irregularly.".

Manufacturer Narrative

H6 - health effect - impact code: "2199" should be removed and "4627" should be added.H6- medical device problem code: "3189" should be removed and "2993" should be added.B5- the reporter indicated the surgeon implanted an implantable collamer lens into the patient's eye.Reportedly , "dr.Called me to share about her patient last week where she had to remove/replace both eyes of the same patient.Backup lenses were implanted.The first eye sounds like she didn't load the lens correctly, resulting in the lens inserting irregularly." the lens was explanted and a replacement lens was implanted.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 91016
• Manufacturer (Section G): STAAR SUGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 17199743
• MDR Text Key: 318278863
• Report Number: 2023826-2023-02503
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• 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