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

Model Number MICL 13.2

Device Problem Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No similar complaint type events were reported for units within the same lot.(b)(4).

Event Description

A completed laf card for a 13.2mm, micl13.2, -10.0 diopter, intraocular lens was returned back to us.Note on the laf card indicated " lens didnt set correctly in eye".Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Patient code 3191 corrected to patient code 2692 in initial mdr.(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
• MDR Report Key: 9131320
• MDR Text Key: 161572573
• Report Number: 2023826-2019-01792
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103299
• UDI-Public: 00841542103299
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: MICL 13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/27/2019
• Supplement Dates Manufacturer Received: 12/03/2019
• Supplement Dates FDA Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention