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

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)

Patient Problems Cataract (1766); Intraocular Pressure Increased (1937); Retinal Detachment (2047); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

H6: health impact- clinical code: 4581 - vitrectomy.Claim # (b)(4).

Event Description

An article was received for "evaluation of the evo/evo+ sphere and toric vision icl: six month results from the united states food and drug administration clinic trial".The trial enrolled 629 eyes of 327 patients.The article reported the following adverse events - transient increase of iop (due to retained ovd); lens repositioning and lens explant/exchange (2 eyes); excessive vaulting; blurred vision (1 eye); cataract development/myopic shift/reduced visual acuity (1 eye); haloes/glare (1 eye); retinal detachment/vitrectomy (3 eyes).Additional information has been requested but none has been forthcoming.

Manufacturer Narrative

B5 - this is regarding a clinical trial that staar conducted.Staar already reports all clinical trial complaints to the complaints department, this complaint should be voided, since we would have already captured all events listed in the article through internal reports.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC 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 ; 6263037902
• MDR Report Key: 17515453
• MDR Text Key: 321044848
• Report Number: 2023826-2023-03415
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2023

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: 07/19/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: No
• 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