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

Model Number	TMICL13.2
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation type 4110: 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 a 13.2mm tmicl13.2 implantable collamer lens, -6.0/+1.5/073 (sphere/cylinder/axis) was implanted into the patient's eye.Reportedly, it will possibly be exchanged due to the lens being too vaulted.Attempts to obtain additional information have not been successful.
Additional Manufacturer Narrative
Additional information: h3- device evaluation: lens was returned in a vial in liquid.Visual inspection found no visible damage to the lens.Claim# (b)(4).
Additional Manufacturer Narrative
Additional information: b5- the reporter indicated that a 13.2mm tmicl13.2 implantable collamer lens; -6.0/+1.5/073 (sphere/cylinder/axis); was implanted into the patient's left eye (os) on (b)(6) 2021.Significant reduction of irido-corneal angles was observed.The lens was removed and replaced on (b)(6) 2021 with a shorter length lens.The problem was resolved.The cause of the event is device; nomogram or pt correspondence to nomogram.Icl oversized causing poor seating and iris left with very narrow angles inferior temp.Quadrant.The reporter stated "icl now lays correctly with no angle compromise.Before exchange i disinserted and inserted foot plates/heptics of original icl to ensure no curling of the foot plates- this did not solve the problem so the icl was exchanged successfully." h6- clinical code 4581: significant reduction of irirdo-corneal angles.Claim# : (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Common Device Name: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 11448819
• Report Number: 2023826-2021-00605
• Device Sequence Number: 4014963
• Product Code: QCB
• UDI-Device Identifier: 00841542108461
• UDI-Public: 00841542108461
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2021

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: 10/31/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 05/25/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 05/03/2021; 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR