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

Model Number TMICL13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Corneal Edema (1791); Intraocular Pressure Increased (1937); Blurred Vision (2137); No Code Available (3191)

Event Date 11/09/2018

Event Type  Injury  

Manufacturer Narrative

Unk.(b)(4).Lens work order search: no similar complaint type events reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 lens, -12.5/+2.0/072 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2018.Reportedly, the patient presented with blurry vision, corneal edema, high iop and excessive vault.The surgeon performed a yag pi and patient was placed on iop medications.Currently, the patient's symptoms are resolving and vision has improved.The lens remains implanted.

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 ; 8002927902
• MDR Report Key: 8129041
• MDR Text Key: 129191756
• Report Number: 2023826-2018-01773
• Device Sequence Number: 0
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2018
• 2 Devices were Involved in the Event: 1 2

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
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• 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: 43 YR