MAUDE Adverse Event Report: STAAR SURGICAL COMPANY MICROSTAAR INJECTOR; INTRAOCULAR LENS FOLDERS AND INJECTORS

Model Number	SFC-45
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The reporter indicated a 12.6mm micl12.6 implantable collamer lens, -09.50 diopter, was damaged (lens split into 2 pieces) and it was unknown if there was any patient contact.The backup lens was implanted.Additional information has been requested but none has been forthcoming.
Additional Manufacturer Narrative
No similar complaint was reported for units within the same lot.Claim # (b)(4).
Additional Manufacturer Narrative
Corrected data: b5: the reporter indicated the surgeon was loading a 12.6mm tmicl12.6 implantable collamer lens, -09.50 diopter, and the lens tore.The lens was replaced with the backup lens and the problem was resolved.The cause of the event was due to the device, the icl was stuck in a defective cartridge.The cartridge was narrow and would not allow the lens to pass through.There was no patient contact.Claim # (b)(4).
Additional Manufacturer Narrative
H3: device evaluation: the cartridge was not returned for evaluation.The lens was returned in a vial, with moisture on the lens.Visual inspection found the lens optic and one haptic torn.H6 - cartridge lot number search: no similar complaint was reported for units within the same lot.H6: device history record (dhr) review: based on the results of the investigation, all released devices from the associated work order(s), including the suspected device, have been manufactured within established process parameters; and there is no indication that the manufacturing and processing of the device contributed to the complaint issue.Claim # (b)(4).

• Brand Name: MICROSTAAR INJECTOR
• Common Device Name: INTRAOCULAR LENS FOLDERS AND INJECTORS
• 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 ; 6263037902
• MDR Report Key: 13014909
• Report Number: 2023826-2021-04805
• Device Sequence Number: 5188226
• Product Code: MSS
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K152357
• 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,Followup
• Report Date (Section B): 11/22/2021
• 2 Devices were Involved in the Event: 1 2

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: 04/30/2022
• Device Model Number: SFC-45
• Device Lot Number: 1492563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 02/14/2022
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 02/04/2022; 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2020
• 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: FOAM TIP PLUNGER MODEL FTP - LOT # 1471040.; INJECTOR MODEL MSI-PF - LOT # UNK.; LENS MODEL MICL12.6, SERIAL # (B)(6).; UNK.
• Patient Age: 29 YR
• Patient Sex: Female