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

Model Number VTICMO13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problems Cyst(s) (1800); Blurred Vision (2137); Halo (2227); Discomfort (2330); No Code Available (3191)

Event Date 10/09/2017

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 13.2 mm vticmo13.2 implantable collamer lens, -1.5/+3.5/170 (sphere/cylinder/axis), into the patient's left eye (os) on (b)(6) 2017.The surgeon reports excessive vault, lens rotation, refractive surprise, significant reduction of irido-corneal angles (ica) (angle closure), haloes, visual discomfort, and anterior chamber irrigation/evacuation of remaining visco/fluids.Also reported is surgical enlargement/addition of new pi, low bcva and ucva, and lens repositioning.The surgeon states that "probably the lens is too big for the eye" but believes that the visual problems of the patient are not related to the lens but to the cornea.He believes that changing the icl will not solve the visual discomfort and that the lens is not doing any harm to the patient.The lens remains implanted.The patient is "not happy with his visual acuity.".

Manufacturer Narrative

The surgeon noted that "the iris cyst was not suspected before the surgery.The suspicion was risen after the first by the fact that the vault was uneven and that with dilation always gets more even and with a normal height.And the cyst suspicion was even stronger after the second surgery since re-accommodation of the icl did not change the behavior of the lens." work order search: no similar complaint type events were reported for units within the same lot.Conclusion code: previous code is not applicable, keratoconus is no longer considered a contraindication.(b)(4).

Manufacturer Narrative

(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 ; 6263037902
• MDR Report Key: 7152455
• MDR Text Key: 95971427
• Report Number: 2023826-2017-01962
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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,Followup
• Report Date: 11/30/2017

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: 03/31/2020
• Device Model Number: VTICMO13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 02/15/2018; 03/07/2018; 03/13/2018
• Supplement Dates FDA Received: 02/15/2018; 03/07/2018; 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2016
• 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: 39 YR