MAUDE Adverse Event Report: STAAR SURGICAL COMPANY IMPLANTABLE COLLAMER LENS; INTRAOCULAR LENS

Model Number VICM6_13.2

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Blurred Vision (2137)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

Product manufactured but not sold in the u.S.Lens work order search: one similar complaint type event reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2 mm vicm6_13.2 implantable collamer lens, -5.5 diopter into the patient's left eye (os) on (b)(6) 2018.The surgeon reports >2-line drop of bcva at the 1-month postoperative visit.Upon the repeat exam of the bcdva during a follow up visit, it was determined that, although there was a 1-line improvement in the best corrected vision of the eye, it is still a 2-line drop from preoperative values.The lens remains implanted and investigation is ongoing.

Manufacturer Narrative

Additional information: in the surgeon's opinion, the cause of this event is the device.The status of the patient's eye is "resolving." (b)(4).

Manufacturer Narrative

Additional information: event is determined to be resolved.Subject completed the study on (b)(6) 2018 with bcdva of 20/20.It is the medical monitor's opinion that the transient decrease and subsequent improvement in bcdva reflect's the subject's process of neuroadaptation to the edof optic.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: 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 ; 8002927902
• MDR Report Key: 7660090
• MDR Text Key: 113072124
• Report Number: 2023826-2018-01003
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/13/2018

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: 09/30/2020
• Device Model Number: VICM6_13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/12/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 08/02/2018; 09/20/2018; 05/23/2019
• Supplement Dates FDA Received: 08/28/2018; 09/20/2018; 06/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2018
• 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
• Treatment: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJECTOR MODEL-MSI-PF, LOT#-UNK
• Patient Outcome(s): Other
• Patient Age: 49 YR