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

Device Problems Misfocusing (1401); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problems Cataract (1766); Blurred Vision (2137)

Event Type  Injury  

Manufacturer Narrative

Product code: unk; esubmitter software does not allow for a blank/unk entry.This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

An article published in scientific reports was received on 18-dec-2020, entitled 'etiology and outcomes of current posterior chamber phakic intraocular lens extraction.' the article states that icl extraction was required in a total of 8 out of 770 eyes.Five of the eyes experienced progression of pre-existing cataract formation; including nuclear cataract (2 eyes); anterior subcapsular cataract in the peripheral area (1 eye) and paracentral area (2 eyes).Three eyes had residual refractive errors immediately after initial surgery due to inaccurate icl power calculation.In the cases of cataract formation phacoemulsification and iol implantation was performed.In the cases of residual refractive errors the explanted lens was replaced with a replacement icl.

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: UNK
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016 ; 8002927902
• MDR Report Key: 11159193
• MDR Text Key: 226771035
• Report Number: 2023826-2021-00122
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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