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

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Cataract (1766); Eye Injury (1845); Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

An article published in bmc ophthalmology was received on (b)(6) 2021, entitled 'reasons for explantation of phakic intraocular lenses and associated perioperative complications: cross-sectional explant registry analysis.' the article states that 4 eyes were explanted due to development of a cataract: 1 anterior subcapsular; 2 nuclear; 1 posterior subcapsular; and 1 of the 4 eyes also had corneal endothelial damage.An additional 1 eye was explanted due to oversizing leading to intermitted iop increase and pigment dispersion.2 additional eyes were explanted due to photopic phenomena.

• 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: 11448857
• MDR Text Key: 238941207
• Report Number: 2023826-2021-00612
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/12/2021

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: 02/12/2021
• Initial Date FDA Received: 03/09/2021
• 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