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

Model Number VICM5_12.1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Edema (1791); Corneal Clouding/Hazing (1878); Inflammation (1932); No Code Available (3191)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S (b)(4).Work order search: no similar complaint was reported for units within the same lot.Claim # (b)(4).

Event Description

The reporter indicated the surgeon implanted a 12.1mm vicm5_12.1 implantable collamer lens, - 08.50 diopter, in the patients right eye (od), on (b)(6) 2019.The lens was explanted on (b)(6) 2019 due to severe anterior segment reaction.The reporter indicated the inflammation was tass.At the post-op visit on (b)(6) 2019, the total cornea was haze and edema was improving with intense topical and systemic steroid medications.The patients current status is improvement in va 6/6p, ocular status is normal and cornea is good and clear.The lens was not exchanged for another lens.

Manufacturer Narrative

Device evaluation: the lens was returned dry in a micro-centrifuge vial, with residue on the lens.Visual inspection found no visible damage to the lens.Device history record (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.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: 8445704
• MDR Text Key: 139621132
• Report Number: 2023826-2019-00471
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/05/2019

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: 10/31/2021
• Device Model Number: VICM5_12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Initial Date Manufacturer Received: 03/05/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/22/2019
• Supplement Dates FDA Received: 05/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK; CARTRIDGE MODEL SFC-45 - LOT # UNK; FOAM TIP PLUNGER MODEL FTP - LOT # UNK; INJECTOR MODEL MSI-PF - LOT # UNK
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR