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

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

H6- clinical code 4581: endothelial cell loss.Claim# (b)(4).

Event Description

A retrospective analysis was published in journal of cataract & refractive surgery; entitled, 'the causes and outcomes of implantable collamer lens explantation in patients with corneal endothelial cell loss'.The study consisted of 93 eyes from 50 patients who underwent icl explantation.Correlation analysis was performed to assess the ocular parameters associated with ecd loss, while percentage of (ecd) change was monitored up to 6 months postoperatively.In result, high vaulting, high vaulting/anterior chamber depth (acd) low anterior chamber angle (aca), and high iris pigmentations are the significant factors of ecd loss.The study conclusion was that high vaulting is a significant factor in ecd loss among icl inserted patients.To prevent continuous ecd loss in icl patients, close monitoring of ecd and making appropriate decisions regarding explantation may be necessary.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: h6 device code: 2923, 1583 in previous mdr is not applicable, device code corrected to 2993.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
• MDR Report Key: 18982103
• MDR Text Key: 338659809
• Report Number: 2023826-2024-01257
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• 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
• Date Manufacturer Received: 03/26/2024
• 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