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

Model Number	MICL 13.7 (-13.0)
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Intraocular Pressure Increased (1937)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The reporter indicated that a implantable collamer lens was implanted into the patient's eye.Pressure spikes were observed.Lens remains implanted.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
B3 - additonal information - 10-dec-2024.B5- reported as; the reporter indicated that a 13.7mm micl 13.7 of -7.0 diopter implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2020.Elevated iop; significant reduction of irido-corneal angles was reported.Patient stated "she noticed haloes around any lights.The lens remains implanted; however, the surgeon performed enlargement of pi; and it is reported that the surgeon has gone back and performed a second iridotomy.Patient states no pain or vision changes.The left eye pressure is ok.- correct to; a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop (32mmhg) without pupil block and angle colsure; significant reduction of irido-corneal angles.Enlargement of pi.Uveitie/iritis.Lens remains implanted.Additional information was requested.No further information is available at this time.This file will be re-opened if additional information is provided.There are multiple medical device reports associated with this patient.This report is 1 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.D4: update data:primary unique device identifier (udi)#: (b)(4)."udi related data quality updates only".D6a; update data; 10/jun/2020.H6 health effect - clinical code; reported as; 2227-4581significant reduction of irido-corneal angles - additional information - 1940, 2122.Claim#(b)(4).Manufacturer narrative - iritis is an inflammatory condition which is common after intra-ocular surgery, however this is usually mild and does not require any additional interventions beyond the standard post-op regimen.In some cases, the degree of inflammation may be more severe and require extended steroid treatment.Procedural factors including excessive surgical manipulation and the use of pro-inflammatory substances in the eye may have contributed to the event.Mechanical insult to the iris can result in a prolonged or stronger inflammatory response.An exact cause could not be determined as the event could be multifactorial in nature including patient and/or procedure related factors.
Additional Manufacturer Narrative
B5 - corrected to: a healthcare professional reported that following an implantable collamer lens (icl) implantation procedure, the patient experienced elevated iop and significant reduction of iridocorneal angles.Enlargement of pi was required.Angle closure occurred and an additional pi was performed.The surgeon determined an exchange for a smaller size lens was required, as that was the cause for the reported events.The lens was explanted & replaced with a shorter length lens.The problem was resolved.There are multiple medical device reports associated with this patient.This report is 2 of 2 total reports.Based on the information provided, the risk assessment for our product, and our experience, we have determined the cause or contribution to the reported issue is not indicative of a manufacturing related issue or product deficiency.H6 - work order search: no additional similar complaints found within associated lots.Claim# (b)(4).

• Brand Name: VISIAN ICL (IMPLANTABLE COLLAMER LENS)
• Common Device Name: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer (Section G): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• Manufacturer Contact: cynthia thai ; 1911 walker avenue; monrovia, CA 91016
• MDR Report Key: 10515448
• Report Number: 2023826-2020-02023
• Device Sequence Number: 4284323
• Product Code: MTA
• UDI-Device Identifier: 00841542103626
• UDI-Public: (01)00841542103626(17)220331
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: N/A#S-P#N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/17/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: MICL 13.7 (-13.0)
• Device Catalogue Number: MICL 13.7
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 02/27/2025; 06/19/2025
• Initial Report FDA Received Date: 09/10/2020
• Supplement Report FDA Received Date: 03/24/2025; 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE MODEL: SFC-45 LOT# 1469706.; INJECTION SYSTEM: FOAM TIP PLUNGER LOT# 1466366.; INJECTOR MODEL: MSI-PF LOT# 1455557.; UNK.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female