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

Model Number VTICM5_12.6

Device Problems Material Opacification (1426); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.No similar complaint was reported for units within the same lot.(b)(4).

Event Description

The reporter indicated a 12.6mm vticm5_12.6 implantable collamer lens, -5.00/+1.5/082 (sphere/cylinder/axis), was removed from the vial and was noted to be opaque.The lens was not used and there was no patient contact.The surgeon implanted a longer lens that was available, and the problem was resolved.The patients eye is stable.The cause of the event was unknown.

Manufacturer Narrative

Additional information: b5: "the reporter stated that when the surgeon opened the lens he saw something like bubble on the lens surface." should be added to the initial mdr.Claim#: (b)(4).

Manufacturer Narrative

Additional information: h3: lens was returned in liquid with clear surgical residue and moisture in a lens vial.Visual inspection found no visible damage and foreign residue on the lens.Claim# (b)(4).

Manufacturer Narrative

Additional information: h6- device history review- (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.Corrected data: h6- device code: 2975 is not applicable in previous mdr claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS (ICL)
• Type of Device: PHAKIC TORIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 9684576
• MDR Text Key: 190640873
• Report Number: 2023826-2020-00260
• Device Sequence Number: 1
• Product Code: QCB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/15/2020

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: 10/31/2022
• Device Model Number: VTICM5_12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Initial Date Manufacturer Received: 01/15/2020
• Initial Date FDA Received: 02/07/2020
• Supplement Dates Manufacturer Received: 03/09/2020; 05/18/2020; 08/18/2020
• Supplement Dates FDA Received: 04/08/2020; 06/18/2020; 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR