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

Model Number VICM5_12.1

Device Problem Positioning Failure (1158)

Patient Problem No Code Available (3191)

Event Date 01/06/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.Secondary surgery, lens exchange.Work order search: no similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a vicm5_12.1, -11.5 diopter, implantable collamer lens in the patient's right eye (od) on (b)(6) 2018.After the surgery the surgeon felt something wrong because "the visual acuity outcome was poor." on (b)(6) 2018, the lens was explanted due to the lens being upside down.The lens was exchanged for a similar lens and the problem was resolved.

Manufacturer Narrative

Additional information: device evaluation: the lens was returned in a micro centrifuge vial with moisture on lens.Visual inspection found a tear in the haptic.(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
• MDR Report Key: 7335043
• MDR Text Key: 102248603
• Report Number: 2023826-2018-00339
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 02/13/2018

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: 12/31/2019
• Device Model Number: VICM5_12.1
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2018
• Initial Date FDA Received: 03/13/2018
• Supplement Dates Manufacturer Received: 04/04/2018
• Supplement Dates FDA Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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
• Treatment: CARTRIDGE LOT #: 1372128; CARTRIDGE MODEL: SFC-45; INJECTOR LOT #: 1378689; INJECTOR MODEL: MSI-PF
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR