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

Model Number MICL13.7

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problems Intraocular Pressure Increased (1937); Nausea (1970); Pain (1994); No Code Available (3191)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The reporter stated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -10.5 diopter, in the patient's right eye (od) on (b)(6) 2017.The patient returned the next day, (b)(6) 2017, in pain, nauseous, with a pressure spike (60mmhg) and steamy eye.Another iridotomy was performed and pressure dropped down to 40mmhg.The chamber was shallow, with some angle closure and the surgeon decided to explant the lens the same day.A shorter lens (13.2mm) was implanted but the pressure again spiked and the lens was explanted same day ((b)(6) 2017) - see mdr #2023826-2017-01383.A third lens was not implanted.The lens was discarded.The patient is doing fine.

Manufacturer Narrative

(b)(4).Device manufacturer date: it is corrected to 23-dec-2016.(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 6832459
• MDR Text Key: 84069740
• Report Number: 2023826-2017-01382
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103572
• UDI-Public: 00841542103572
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/02/2017

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: 11/30/2018
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/30/2017
• Supplement Dates Manufacturer Received: 10/16/2017
• Supplement Dates FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/23/2016
• 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: 31 YR