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

Model Number	MICL12.6
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No similar complaint was reported for units within the same lot.(b)(4).
Event or Problem Description
The reporter indicated the surgeon inserted and removed a 12.6mm micl12.6 implantable collamer lens, +05.50 diopter, within the same surgery due to the lens flipped upside down in the eye upon insertion.There was no patient injury.The lens was replaced with another icl lens.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch will be submitted.The cause of the event was unknown.
Additional Manufacturer Narrative
Additional data: b5: the reporter indicated the replacement lens resolved the problem and the patient is seeing very well.H3 - device evaluation: the lens was returned dry in a specimen cup, with residue on the lens.Visual inspection found the optic and haptic torn.Corrected data: d10: returned to manufacturer: 08-jun-2020.(b)(4).
Additional Manufacturer Narrative
Corrected data: b1: updated to adverse events.B2: updated to required intervention to prevent permanent impairment/damage.H1: updated to serious injury.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
• MDR Report Key: 10189318
• Report Number: 2023826-2020-01276
• Device Sequence Number: 14135494
• Product Code: MTA
• UDI-Device Identifier: 00841542102933
• UDI-Public: 00841542102933
• Combination Product (Y/N): N
• 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): 06/01/2020

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: 09/30/2020
• Device Model Number: MICL12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 07/01/2020; 07/01/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/29/2020; 06/03/2021
• 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 # 1460486; FOAM TIP PLUNGER MODEL FTP - LOT # 1436715; INJECTOR MODEL AND LOT # UNK
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR