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

Model Number	TMICL13.7
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Corneal Decompensation (1790); Corneal Edema (1791); Intraocular Pressure Increased (1937); Pupillary Block (2026); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 13.7mm tmicl13.7 implantable collamer lens -15.5/+2.0/092 (sphere/cylinder/axis) into the patient's right (od) eye.The surgeon reportedly explanted the lens and replaced it with a shorter lens because the lens was "too big.".
Additional Manufacturer Narrative
B5: additional information: excessive vault-touching the cornea, elevated iop, 4+ corneal edema, corneal decompensation, pigment dispersion, unreactive (fixed) pupil, blurred vision reported.Cause is reported as device: icl too larger per calculator.Problem marked as resolved.However, see mfr rep# 2023826-2021-00704 for replacement lens.Original lens implanted, removed, and replaced within the same surgery.Claim #(b)(4).
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned in liquied in a vial.Visual inspection found that the haptic was torn.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: 11558806
• Report Number: 2023826-2021-00699
• Device Sequence Number: 4781035
• Product Code: QCB
• UDI-Device Identifier: 00841542111973
• UDI-Public: 00841542111973
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• 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): 02/24/2021

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: 01/31/2022
• Device Model Number: TMICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/23/2021; 04/20/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/12/2021; 05/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL-SFC-45, LOT#-UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 32 YR