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

Model Number	TMICL13.2
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Optical Problem (3001)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Visual Disturbances (2140); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 13.2mm tmicl13.2 implantable collamer lens -15.5/+2.5/091 (sphere/cylinder/axis) into the patient's left (os) eye.The surgeon reports iop controlled with alphagam, high vault, shallow ac, "crappy" vision at 20/200.Pupil is dilated and ar is +2.75.
Additional Manufacturer Narrative
B5-additional information: refractive surprise, significant reduction of ica, pigment dispersion, unreactive (fixed) pupil, hyperopic surprise +2.00, glare/halos, blurred vision.Reportedly vision is now "ok" at +1.00 hyperopic.Pilocarpine used to constrict pupil and set the icl in the sulcus.H6-clinical code 4581 (significant reduction of ica, pigment dispersion, unreactive/fixed pupil).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: 11558794
• Report Number: 2023826-2021-00700
• Device Sequence Number: 4767126
• Product Code: QCB
• UDI-Device Identifier: 00841542109819
• UDI-Public: 00841542109819
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 09/30/2022
• Device Model Number: TMICL13.2
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/12/2021
• 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.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 32 YR