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

Model Number	TMICL12.6
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/07/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight: unk, ethnicity: unk, race: unk.(b)(4).Lens work order search: 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 12.6mm tmicl13.2 lens, -12.5/+3.0/092 (sphere/cylinder/axis) into the patient's right (od) eye on (b)(6) 2019.On (b)(6) 2019 the lens was exchanged with a longer lens due to lens rotation.The problem was resolved.
Additional Manufacturer Narrative
"tmicl13.2" should be corrected to "tmicl12.6" in initial medwatch report."patient's right (od) eye" should be corrected to "patient's left eye (os)" "the lens was exchanged" should be corrected to "the lens was explanted and replaced "."patient code 3191 : no code available (secondary surgery, lens exchange)" should be corrected to "patient code 3191 : no code available (secondary surgery, lens explant)".(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: 8671664
• Report Number: 2023826-2019-01012
• Device Sequence Number: 18892985
• Product Code: QCB
• UDI-Device Identifier: 00841542107235
• UDI-Public: 00841542107235
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: TMICL12.6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2019
• Supplement Date Received by Manufacturer: 08/20/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 08/20/2019
• 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
• Patient Age: 26 YR