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

Catalog Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Optical Problem (3001)

Patient Problems Cataract (1766); Glaucoma (1875); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Blurred Vision (2137); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

H6 - health effect clinical code: 4581 - cell loss, decentration, pigment dispersion, trabulectomy, choroidal neovascularization, macular hole, claim#: (b)(4).

Event Description

An article published titled "phakic intraocular lenses: an overview" has a section that reports data about a study of an overview of 1000+ eyes for staar surgical icl's.During this study it notes patient adverse events varied from significant opacities, cell loss, subluxation needing an exchange, incorrect sizing needing an exchange, retinal detachment, rotation with reposition, asymptomatic anterior cataract, choroidal neovascularization, macular hole, central pigment atrophy, increased iop requiring treatment, iritis, additional laser refractive correction, glare and halos, lens explantation due to decentration and acute glaucoma, pigment dispersion requiring trabeculectomy, small vault due to incorrect haptic placement in the sulcus.The article concludes with noting phakic iol implantation in highly myopic patients is associated with excellent visual and refractive outcomes shortly after surgery.Due to age related and morphometric changes, visual and refractive outcomes might change over time.The exact mechanisms causing this are yet unknown and require additional research to formulate definitive recommendations.Until then, surgeons implanting poils in highly myopic patients should inform their patients of the possibility that their refractive error might change slightly over time.As shown by the large variability in the reported data, there are still large variations in the assessment and description of complications occurring in patients with poils.

• 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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: joselene muniz ; 1911 walker avenue; monrovia,, CA 91016
• MDR Report Key: 18584590
• MDR Text Key: 333772996
• Report Number: 2023826-2024-00441
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/18/2024

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 Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 01/25/2024
• 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