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

Model Number VICMO12.6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); Corneal Ulcer (1796); Endophthalmitis (1835); No Code Available (3191)

Event Date 12/12/2018

Event Type  Injury  

Manufacturer Narrative

The product is manufactured in the us, but not marketed in the us.(b)(4).One similar complaint type event reported for units within the same lot.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.6mm vicmo12.6 implantable collamer lens, diopter -14.5 into the patient's right eye (od) on (b)(6) 2018.On the same day, corneal edema and inflammatory cells developed in the anterior chamber.Diagnostic tests were performed and the surgeon reports endophthalmitis.No aqueous samples were taken.Steroid eye drops, oral medicine, and eye drops with hypotensive effect were administered.Currently, the patient is recovered.The cause of the event is reported as unknown.

Manufacturer Narrative

Patient code: 7196 is not applicable and should be corrected to patient code: 3191: no code available (inflammatory cells) in previous mdr.Claim#: (b)(4).

Manufacturer Narrative

Method code 3331, 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).

Manufacturer Narrative

Patient code 1791: corneal edema.Patient code 1796: inflammatory cells.(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
• MDR Report Key: 8552498
• MDR Text Key: 143220875
• Report Number: 2023826-2019-00660
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2019

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: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: VICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 05/16/2019; 07/29/2019; 08/13/2019
• Supplement Dates FDA Received: 06/12/2019; 08/08/2019; 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-1412190
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR