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

Model Number VTICMO12.6

Device Problems Optical Decentration (1360); Misfocusing (1401); Off-Label Use (1494); Device Dislodged or Dislocated (2923)

Patient Problems Blurred Vision (2137); No Code Available (3191)

Event Date 06/03/2019

Event Type  Injury  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.Pma/510k: this product is not marketed in the us.(b)(4).Work order search: no similar complaint type events were reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated that a 12.6mm, vticmo12.6, 15.00/2.5/90 (sphere/cylinder/axis), implantable collamer lens was implanted into the patients right eye (od) on (b)(6) 2019.Lens rotation not associated to a low vault and refractive surprise was observed.Repositioning was performed but it did not resolve the problem.The reporter stated " there is a constant decentration of the ticl due to its small diameter.It is necessary to exchange it and replace it with a larger one".At patients last visit "decentered ticl/ bad vision" was reported.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 code 1360: lens decentration, device code 1494: off- label use.Anterior chamber depth (acd) outside indicated ranges (less than 3.0mm).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: 8902020
• MDR Text Key: 154574185
• Report Number: 2023826-2019-01475
• 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
• Report Date: 07/18/2019

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: 02/28/2022
• Device Model Number: VTICMO12.6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 09/05/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL: SFC-45, LOT # 1426501; FOAM TIP PLUNGER, LOT # 1422732; INJECTOR MODEL: MSI-TF, LOT # 1427762; CARTRIDGE MODEL: SFC-45, LOT # 1426501; FOAM TIP PLUNGER, LOT # 1422732; INJECTOR MODEL: MSI-TF, LOT # 1427762
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR