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

Model Number	MICL12.6
Medical Device Problem Codes	Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Blurred Vision (2137); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/17/2020
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.
Event or Problem Description
The reporter indicated that the surgeon implanted a 12.6mm micl12.6 implantable collamer lens, -14.5 diopter, into the patient's eye on (b)(6) 2020.On (b)(6) 2020 the surgeon explanted the lens due to elevated iop.
Additional Manufacturer Narrative
Claim#: (b)(4).
Additional Manufacturer Narrative
H3-device evaluation: the lens was returned dry in a specimen cup with residue on the product.Visual inspection found residue on the lens and that the lens is curved in.Claim#: (b)(4).
Additional Manufacturer Narrative
B5: additional information: lens had been implanted into the od eye.Additional symptoms reported: excessive vault, angle closure, blurred vision.Addition of new pi-yag, phaco-emulsification and iol implantation.Performed refractive lens exchange with pupilloplasty and posterior synechiaelysis on (b)(6) 2020.Status: pseudophakia, encouraged to use +1.25 readers to help with computer and phone.Cause of the event is reported as a patient-related factor, "eye couldn't handle device." h6: linical code 4581 (angle closure).Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 10544158
• Report Number: 2023826-2020-02118
• Device Sequence Number: 11540656
• Product Code: MTA
• UDI-Device Identifier: 00841542103114
• UDI-Public: 00841542103114
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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,Followup
• Report Date (Section B): 08/21/2020

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: 11/30/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/18/2020; 10/26/2020; 10/23/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 10/15/2020; 11/03/2020; 11/17/2020
• 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: Required Intervention
• Patient Age: 33 YR