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

Model Number MICL 13.2

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Intraocular Pressure Increased (1937); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Work order search: no similar complaint type events were reported for units within the same lot.Patient code:(b)(4) secondary surgical intervention, exchanged, angle closure.(b)(4).

Event Description

The reporter indicated that the surgeon implanted a 13.2mm micl13.2, -10.5 diopter , implantable collamer lens and resulted in a very high vault , angle closure with elevated iop (intraocular pressure) was also observed.The lens was exchanged for a shorter length lens.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: (b)(4).

Manufacturer Narrative

Corrected data: correct patient identifier is (b)(6) not (b)(6).Complaint is an adverse event; secondary surgery was performed to exchange lens.Therefore, product problem is incorrect.Claim # (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: 7583196
• MDR Text Key: 110509196
• Report Number: 2023826-2018-00869
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103305
• UDI-Public: 00841542103305
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2018

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?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: MICL 13.2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/08/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/08/2018
• Supplement Dates FDA Received: 08/01/2018; 08/08/2018
• Date Device Manufactured: 10/30/2017
• 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