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

Model Number VTICMO12.6

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

Patient Problems Corneal Decompensation (1790); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Blurred Vision (2137); Visual Disturbances (2140); Halo (2227); No Code Available (3191)

Event Date 12/13/2017

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 that the surgeon implanted a 12.6 mm vticmo12.6 implantable collamer lens, -17.0/+2.0/170 (sphere/cylinder/axis), into the patient's right eye (od) on (b)(6) 2017.On (b)(6) 2017 the lens was explanted.The surgeon notes the following: excessive vault, significant reduction of irido-corneal angles (ica), corneal decompensation, pigment dispersion, unreactive (fixed) pupil, glare/haloes, blurred vision, inflammation, and "choroidal detachment, severe hypotension." reporter states that hypotension is "being resolved" and "in fact the patient is very good.".

Manufacturer Narrative

A lens work order search was performed.No similar complaint type events were found.Returned product evaluation found the lens returned dry in a lens case/vial with clear surgical residue/debris on product.Visual inspection found no visible damage to lens.Measurement of the hydration found moisture content on a high level; but not exceeding limits.The overall lens diameter was then found out of tolerance.The lens sn: (b)(4) was a 12.6mm implantable lens that is 0.22mm larger than the theoretical; the tolerance is +/-0.20mm.Since the work order search did not find additional similar errors to this complaint event, it can be concluded that the oos condition is not likely due to manufacturing or packaging.(b)(4).

Manufacturer Narrative

Device evaluation: measurement of the hydration found the lens to be overhydrated.(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: 7300916
• MDR Text Key: 101093336
• Report Number: 2023826-2018-00281
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2018

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
• Device Expiration Date: 03/31/2020
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/27/2018
• Supplement Dates Manufacturer Received: 03/08/2018; 05/07/2018
• Supplement Dates FDA Received: 04/09/2018; 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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: 44 YR