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

Device Problem No Apparent Adverse Event (3189)

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

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

A4: unk.A5: unk.A6: unk.H6 - work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated a 13.2mm vicm5_13.2 implantable collamer lens, -07.00 diopter, didn't advance normally during injection and the lens was damaged.There was patient contact but no injury.The lens was replaced with another same model/length lens and the problem was resolved.The eye was normal.The cause of the event was due to the device.

Manufacturer Narrative

The reporter indicated a 13.2mm vicm5_13.2 implantable collamer lens was correctly folded in the injector, but during injection, it didn't advance normally and was damaged.The injector captured and damaged the lens during injection.There was patient contact but no injury.The lens was replaced with another same model/length lens and the problem was resolved.The eye was normal.The cause of the event was the device.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: joselene muniz ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 18632463
• MDR Text Key: 334445560
• Report Number: 2023826-2024-00276
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024
• 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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/30/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # 1661524; FOAM TIP PLUNGER MODEL FTP - LOT # 1652275; INJECTOR MODEL AND LOT # UNK; LENS MODEL VICM5_13.2, SERIAL # (B)(6)
• Patient Age: 35 YR
• Patient Sex: Female