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

Model Number VTICMO12.6

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Endophthalmitis (1835); Hypopyon (1913); No Code Available (3191)

Event Date 07/25/2019

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 the surgeon implanted a 12.6mm vticmo12.6 implantable collamer lens, -8.5/+1.0/095 (sphere/cylinder/axis), in the patients right eye (od), on (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to patient developed endophthalmitis and hypopyon.The surgeon rinsed the patient's eye and gave her medicine.The situation is under control and patient has recovered well.The cause of the event was due to patient related factor, the patient was not paying attention to hygiene.

Manufacturer Narrative

H6 - work order search: no similar complaint was reported for units within the same lot.Claim #: (b)(4).

Manufacturer Narrative

Lens returned dry in a micro-centrifuge vial.Visual inspection found haptic bent claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9583802
• MDR Text Key: 174876587
• Report Number: 2023826-2020-00105
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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
• Report Date: 12/18/2019

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: 04/30/2022
• Device Model Number: VTICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: 02/04/2020; 06/24/2020
• Supplement Dates FDA Received: 02/19/2020; 07/21/2020
• 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 # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR