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

Model Number SFC-45

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2021

Event Type  malfunction  

Event 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.

Manufacturer Narrative

No similar complaint was reported for units within the same lot.Claim # (b)(4).

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).

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
• Type of Device: 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
• MDR Text Key: 285623929
• Report Number: 2023826-2021-04805
• Device Sequence Number: 1
• Product Code: MSS
• UDI-Device Identifier: 00841542103015
• UDI-Public: 00841542103015
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2021

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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/15/2021
• Supplement Dates Manufacturer Received: 01/06/2022; 02/14/2022
• Supplement Dates FDA Received: 02/04/2022; 03/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 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