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

Model Number	TMICL12.1
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Blurred Vision (2137); No Code Available (3191)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight, ethnicity, race: unk.Lens work order search: no similar complaint type events reported for units within the same lot.Claim# (b)(4).
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.1 mm tmicl12.1 lens, -6.5/+4.0/100 (sphere/cylinder/axis) into the patient's left (os) eye on (b)(6) 2019.The surgeon reports low vault ,lens rotation and blurry vision.Reportedly, the lens remains implanted.Cause of the event is reported as unknown.
Additional Manufacturer Narrative
Outcomes attributed to adverse event: required intervention to prevent permanent impairment/damage (devices).The initial lens was exchanged for a longer length lens on (b)(6) 2019.The replacement lens did not resolve the problem.Reference claim# 430733 for replacement lens.Explant date: (b)(6) 2019.Lens returned in liquid in a eye drop bottle.Visual inspection found no visible damage to lens type of reportable event: serious injury.Claim#: (b)(4).
Additional Manufacturer Narrative
Patient code:3191- secondary surgical intervention; lens exchange.Device code:1401- blurred vison.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: 8984823
• Report Number: 2023826-2019-01652
• Device Sequence Number: 11581982
• Product Code: QCB
• UDI-Device Identifier: 00841542104241
• UDI-Public: 00841542104241
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 08/16/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: TMICL12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 08/16/2019
• Supplement Date Received by Manufacturer: 10/08/2019; 11/26/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 11/06/2019; 11/26/2019
• 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: 33 YR