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

Model Number VTICM5_12.6

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Corneal Edema (1791); Edema (1820); Pain (1994); Blurred Vision (2137); No Code Available (3191)

Event Date 07/03/2017

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).Work order search: no similar complaints were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 12.6 mm vticm5_12.6, -4.5/1.5/86 diopter, implantable collamer lens in the patient's left eye (os) on (b)(6) 2017.The next day, signs of toxic anterior segment syndrome, include tearing, pain, blurry vision, eyelid edema, hyperemia, corneal edema, fixed pupil and fibrin clot in the anterior chamber was noticed.Therapy was started with oral prednisolone (60 mg/day) and acetazolamide 250 mm (1+1+1), tropical prednisolone 1 drop per hour, trapicamide, ofloxacine, and bromofenac.The following day, the patient experience less pain, intense hyperemia, less eyelid edema but a very cloudy whitish cornea.Corneal periphery was partially pared and a blood clot was seen in the inferior a.C.An anterior chamber washing was performed as well as the temporal incision witch being sutured with 2 10/00 nylon stiches and intravitreous injection of vancomicine 1mg/0.1 ml and ceftazidime 1.0 mg/0.1 ml.According to the surgeon, the cornea is clearing up and would need to make another surgery to remove the membrane.

Manufacturer Narrative

Device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.(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
• MDR Report Key: 6760836
• MDR Text Key: 81626086
• Report Number: 2023826-2017-01145
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: N/A
• 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
• Report Date: 07/03/2017

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: 02/29/2020
• Device Model Number: VTICM5_12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 08/02/2017
• Supplement Dates Manufacturer Received: 08/10/2017
• Supplement Dates FDA Received: 09/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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: 30 YR