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

Model Number MICL12.6

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intraocular Pressure Increased (1937); Pain (1994); Retinal Detachment (2047); Vitreous Hemorrhage (2143); Halo (2227); Vitrectomy (2643); No Code Available (3191)

Event Date 11/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on (b)(6) 2017 an icl was removed due to retinal detachment.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

The reporter indicated that the surgeon implanted a 12.6mm micl12.6 of -12.0 diopter implantable collamer lens in the patient's right eye on (b)(6) 2017.On (b)(6) 2017 the lens was explanted due to retinal tear leading to its subsequent detachment.The patient also had elevated iop, narrowing of angle and experienced "some halos and floating lights".Additional peripheral iridectomy brought the elevated iop back to pre-op level and the enlargement of peripheral iridotomy performed increased depth.Vitrectomy was also performed.The surgeon reported that the patient is "currently aphakic will need lens implant".(b)(4).Method: no additional similar complaint type event(s) within associated lots were found.(b)(4).

Manufacturer Narrative

The reporter indicated that the surgeon implanted a 12.6mm micl12.6 of -12.0 diopter implantable collamer lens in the patient's right eye on (b)(6) 2017.On (b)(6) 2017 the lens (and natural lens) was explanted due to retinal tear leading to its subsequent detachment.Laser retinopexy was performed followed by pneumatic cryopexy only to have the curtain in patient's vision return.Vitrectomy performed led to vitreous hemorrhage.A second retinal tear was noticed leading to a second vitrectomy, scleral buckle and "lensectomy" or explant of the micl and natural lens.The patient also had elevated iop, narrowing of angle, pain and experienced "some halos and floating lights".Additional peripheral iridectomy bought the elevated iop back to pre-op level and the enlargement of peripheral iridotomy performed increased depth.The surgeon reported that the patient is "currently aphakic will need lens implant".(b)(4).

Manufacturer Narrative

(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: 7119246
• MDR Text Key: 94923466
• Report Number: 2023826-2017-01886
• Device Sequence Number: 1
• Product Code: MTA
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/17/2017

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
• Device Expiration Date: 02/28/2019
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2017
• Initial Date FDA Received: 12/14/2017
• Supplement Dates Manufacturer Received: 12/20/2017; 01/25/2018; 02/15/2018
• Supplement Dates FDA Received: 01/18/2018; 02/09/2018; 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2017
• 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: 35 YR