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

Model Number	MICL13.7
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon implanted a 13.7mm micl13.7 implantable collamer lens, -05.50 diopter, in the patients eye.The lens was reported as excessive vaulting and angle closure.The lens will be explanted and exchanged.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
The lens was implanted in the patients right eye (od) on (b)(6) 2020.The lens was explanted on (b)(6) 2020.The patient experienced elevated intraocular pressure.The lens was exchanged for a shorter lens and the problem was resolved.The cause of the event was due to the device.Device evaluation: the lens was returned in liquid in lens vial.Visual inspection found the lens haptic torn.Date of event: (b)(6) 2020.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: h6 - health effect clinical code: 4581- angle closure.B5 - the reporter indicated that the surgeon implanted a 13.7mm micl13.7 implantable collamer lens; -05.50 diopter into the patient's right eye (od) on 06/aug/2020.On (b)(6) 2020 the lens was exchanged with a shorter length lens due to excessive vaulting, elevated iop with angle closure.This resolved the problem.The cause of the event was reported as the device "suggested lens was too large".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: 10535260
• Report Number: 2023826-2020-01976
• Device Sequence Number: 4092834
• Product Code: MTA
• UDI-Device Identifier: 00841542103473
• UDI-Public: 00841542103473
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2020

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: 10/31/2020
• Device Model Number: MICL13.7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2020
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 03/26/2021
• Initial Report FDA Received Date: 09/15/2020
• Supplement Report FDA Received Date: 11/09/2020; 03/26/2021
• 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 # 1471029.; FOAM TIP PLUNGER MODEL FTP - LOT # 1471718.; INJECTOR MODEL AND LOT # UNK.; UNK.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR