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

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Cataract (1766); Vitrectomy (2643); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

No serial number reported (b)(4).Secondary surgical intervention, explant and cataract surgery with iol implantation.(b)(4).

Event Description

Article stated that the patient's past ocular history was significant for placement of visian icl several years earlier for the treatment of high myopia.Shortly after implantation, the right icl dislocated, requiring removal, at which time the cataract was also extracted and a posterior chamber iol was placed.Several months later, the iol also dislocated, requiring removal and a pars plana vitrectomy, leaving the right eye (od) aphakic.

Manufacturer Narrative

Claim# (b)(4).

Manufacturer Narrative

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 SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 7791357
• MDR Text Key: 117420039
• Report Number: 2023826-2018-01238
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/17/2018

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?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 10/17/2018; 10/25/2018
• Supplement Dates FDA Received: 10/18/2018; 10/25/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention