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

Model Number	MICL13.2
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).
Event or Problem Description
The reporter indicated a 13.2mm micl13.2 implantable collamer lens, -09.00 diopter, tore during the loading process and the lens did touch the patient's eye.There was no patient injury and sutures were not required.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
Additional data: h3: device evaluation: the lens was returned in a microcentrifuge vial, with moisture on lens.Visual inspection found no visible damage to the lens.Corrected data: b5: the reporter indicated a 13.2mm micl13.2 implantable collamer lens, -09.00 diopter, was stuck in the cartridge or injection system and there was no patient contact.The lens was replaced with another same model/length lens and the problem was resolved.The cause of the event was unknown.H6: health effect - impact code: 2645.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: 11917150
• Report Number: 2023826-2021-01737
• Device Sequence Number: 17043173
• Product Code: MTA
• UDI-Device Identifier: 00841542103275
• UDI-Public: 00841542103275
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/06/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/17/2021
• 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 # 1518549; FOAM TIP PLUNGER MODEL FTP - LOT # 1508029; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Age: 43 YR