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

Model Number VICMO13.2

Device Problems Misfocusing (1401); Inadequacy of Device Shape and/or Size (1583); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blurred Vision (2137); Capsular Bag Tear (2639); No Code Available (3191)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

This product is not marketed in the us.(b)(4).

Event Description

The reporter indicated that a vicmo13.2, -10.50 diopter, implantable collamer lens was implanted into the patients left eye (os) on (b)(6) 2018.A vault value of 0-50 with rotation and capsular tear was reported.On (b)(6) 2018 the lens was exchanged and the problem was resolved.In the reporter opinion the cause of this event was patient related factor.Additional information has been requested.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional data: device evaluated by mfr/ device evaluation: the lens was returned in liquid in a lens vial.There was no visible damage to the lens.Corrected data: event - the reporter indicated that a 13.2 implantable collamre lens of -10.50 diopter was implanted into the patient's left eye (os) on (b)(6) 2018.A vault value of 0-50 with rotation and capsular tear was reported.Loss of va was also reported but provided pre-op and post-op data does not support this claim.On (b)(6) 2018 the lens was exchanged and the problem was resolved.It was reported that the cause of the event was a patient related factor.Work order search: no similar complaint types reported for units within this complaint lot.Claim #(b)(4).

Manufacturer Narrative

Corrected data: event - the reporter indicated that a 13.2 vicmo13.2 implantable collamer lens of -10.50 diopter was implanted into the patient's left eye (os) on (b)(6) 2018.A vault value of 0-50 m with rotation and capsular tear was reported.Loss of va was also reported but provided pre-op and post-op data does not support this claim.On (b)(6) 2018 the lens was exchanged and the problem was resolved.It was reported that the cause of the event was a patient related factor.The reporter indicated that the initial lens was 12.6mm but provided the serial number of a 13.2mm lens.No additional information has been forthcoming.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: 8197958
• MDR Text Key: 131468967
• Report Number: 2023826-2018-01925
• Device Sequence Number: 1
• Product Code: MTA
• 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
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: VICMO13.2
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 02/08/2019; 02/08/2019
• Supplement Dates FDA Received: 02/08/2019; 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE: SFC-45 LOT:UNK; FOAM TIP PLUNGER MODEL-FTP, LOT#-UNK; INJ:MSI-PF, LOT# UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR