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

Model Number MICL12.1

Device Problems Positioning Failure (1158); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 04/26/2018

Event Type  Injury  

Manufacturer Narrative

Lens was returned in liquid, in lens vial.Visual inspection found no visible damage to the lens.A lens work order search was performed.No similar complaint type events found.(b)(4).

Event Description

The reporter stated that a 12.1mm, micl12.1, -12.5 diopter, implantable collamer lens was implanted in the patient's left eye (os) upside down, the lens was removed and the backup lens was used.The reporter stated that there was no patient injury.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.

Manufacturer Narrative

Corrected information: date of event was changed to (b)(6) 2018 previous reported date was incorrect.(b)(4).The lens was not implanted upside down as initially reported.The lens was implanted on (b)(6)) 2018 and exchanged on (b)(6) 2018 due to observation of low vault, elevated iop (intraocular pressure) without pupil block and significant reduction of irido-corneal angles.The reporter stated that the cause of event was due to patient related factor.(b)(4).

Manufacturer Narrative

-implantable collamer lens was implanted in the patient's right eye (od).(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: 7648241
• MDR Text Key: 112695636
• Report Number: 2023826-2018-00973
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542102803
• UDI-Public: 00841542102803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/29/2018

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: 08/31/2019
• Device Model Number: MICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/29/2018
• Initial Date FDA Received: 06/28/2018
• Supplement Dates Manufacturer Received: 07/02/2018; 09/10/2018
• Supplement Dates FDA Received: 08/01/2018; 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2017
• 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: 24 YR