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

Model Number MICL13.2

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Patient Involvement (2645)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The reporter indicated the surgeon removed a 13.2mm micl13.2 implantable collamer lens, -9.5 diopter, from the vial and was preparing the lens to load into the cartridge.The reporter indicated the lens felt harder than normal and was difficult to load.There was no patient contact.The backup lens was implanted with no problem.

Manufacturer Narrative

H3 - device evaluation: lens was returned in a vial in liquid.Visual inspection found no visible damage to the lens.Claim#: (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9535967
• MDR Text Key: 191265428
• Report Number: 2023826-2019-02500
• Device Sequence Number: 1
• Product Code: MTA
• UDI-Device Identifier: 00841542103282
• UDI-Public: 00841542103282
• Combination Product (y/n): N
• PMA/PMN Number: P030016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

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: 01/31/2020
• Device Model Number: MICL13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1