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

Model Number TMICL13.2

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated that a 13.2mm, tmicl13.2, -15.50/4.0/121 (sphere/cylinder/axis) implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019.It was reported that excessive vault was observed, lens remains implanted.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Corrected data: b5 - it was reported the patient also experienced lens rotation.Claim#: (b)(4).

Manufacturer Narrative

Corrected data: h6 - device code: 2923 should have been included in inital medwatch report.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: IMPLANTABLE COLLAMER LENS (ICL)
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9533649
• MDR Text Key: 191265319
• Report Number: 2023826-2019-02516
• Device Sequence Number: 1
• Product Code: QCB
• UDI-Device Identifier: 00841542109840
• UDI-Public: 00841542109840
• 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,Followup
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: TMICL13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 02/07/2020; 03/06/2020
• Supplement Dates FDA Received: 02/07/2020; 03/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Age: 24 YR