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

Model Number MSI-PF

Device Problems Device Issue (2379); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/03/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device not returned.

Event Description

The reporter stated the surgeon inserted a 12.6mm micl12.6 implantable collamer lens, -12.0 diopter, in the patient's eye and the lens tore.There was no patient injury at removal.The backup lens was implanted.The reporter stated the cause of the event may be due to the injector.Additional information has been requested but none has been forthcoming.If additional information is received, a supplemental medwatch report will be submitted.

Manufacturer Narrative

Device evaluated by manufacturer: no, the product pertaining to this complaint was not returned for evaluation.However, the lens was returned and visual inspection of the returned product found the lens torn into two pieces with a piece of one haptic torn off and missing.The lens was returned in vial in liquid.(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: michelle andres ; 1911 walker avenue; monrovia, CA 91016 ; 6263037902
• MDR Report Key: 5755917
• MDR Text Key: 48360373
• Report Number: 2023826-2016-00868
• Device Sequence Number: 1
• Product Code: MSS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: MSI-PF
• Device Catalogue Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45 FP - LOT NUMBER: UNK
• Patient Age: 23 YR