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

Device Problem Positioning Failure (1158)

Patient Problems Cataract (1766); Retinal Detachment (2047); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a v4 implantable collamer lens.The lens was explanted after being implanted in the patients eye 3 years ago, due to inverse icl, a rhegmatogenous retinal detachment and anterior subcapsular cataract.Phacoemulsification surgery was performed and an iol (intraocular lens) was implanted.The reporter attributed the retinal detachment to high myopia.

Manufacturer Narrative

The reporter indicated that the surgeon implanted a v4 implantable collamer lens.The lens was explanted after being implanted in the patient's eye for 3 years due to inverse icl; a rhegmatogenous retinal detachment and anterior subcapsular cataract.Phacoemulsification surgery was performed and an iol (intraocular lens) was implanted.(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 ; 6263037902
• MDR Report Key: 7275445
• MDR Text Key: 100230121
• Report Number: 2023826-2018-00228
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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,Followup
• Report Date: 01/17/2018

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: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/15/2018
• Supplement Dates Manufacturer Received: 04/18/2018
• Supplement Dates FDA Received: 04/19/2018
• 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
• Patient Age: 26 YR