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 Codes	Intraocular Pressure Increased (1937); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint type events reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 13.2mm tmicl13.2 lens, -9.5/+2.5/091 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2020.The surgeon reports "size seems to be big, with persistent elevated iop refractive to medical treatment." the surgeon plans to increase the size of the pi and will determine if an exchange is needed.It is unknown at this time as to whether the pi was increased or the exchange occurred.
Additional Manufacturer Narrative
Additional information: h6 - patient code 3191: no code available (secondary surgery, yag- enlargement of pi).Claim#: (b)(4).
Additional Manufacturer Narrative
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
• MDR Report Key: 9842787
• Report Number: 2023826-2020-00506
• Device Sequence Number: 16865373
• Product Code: QCB
• UDI-Device Identifier: 00841542108973
• UDI-Public: 00841542108973
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2020
• Supplement Date Received by Manufacturer: 04/01/2020; 06/25/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/27/2020; 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention