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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 13.2mm tmicl13.2 implantable collamer lens, -11.00/+1.5/104 (sphere/cylinder/axis), within the same surgery due to sizing issue (too large).There was no patient injury.The lens was exchanged for a shorter lens on (b)(6) 2020 and the problem was resolved.
Additional Manufacturer Narrative
B5: the ovd irrigation and evacuation was performed intra-operative during implantation of the initial lens.Post-op the bcva was 20/20 and good post-op appearance.The lens was not returned.Claim # (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10740471
• Report Number: 2023826-2020-02477
• Device Sequence Number: 14218160
• Product Code: QCB
• UDI-Device Identifier: 00841542109161
• UDI-Public: 00841542109161
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR