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

Model Number VICMO13.2

Device Problems Misfocusing (1401); Off-Label Use (1494)

Patient Problem Visual Impairment (2138)

Event Date 06/22/2020

Event Type  Injury  

Manufacturer Narrative

This product is manufactured in the u.S.But not marketed in the u.S.(b)(4).

Event Description

The reporter indicated the surgeon implanted a 13.2mm vicmo13.2 implantable collamer lens, -15.50 diopter, in the patients right eye (od), on (b)(6) 2020.The lens was explanted on (b)(6) 2020 due to patient experienced a refractive surprise.The lens was exchanged for a same length but different model and diopter lens and the problem was resolved.The cause of the event was unknown.The patient complained of unsatisfactory visual acuity and asked to be replaced with a ticl lens.

Manufacturer Narrative

H3: device evaluation: the lens was returned dry in micro-centrifuge vial.Visual inspection found the haptic broken.The lens was returned significantly damaged which can cause difficulty when centering the lens during functional inspection.Dimensional and refractive verification was performed.The lens width and length was in specification but refraction (functional) verification failed.H6 - work order search: no similar complaint was reported for units within the same lot.H6: 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: 11058380
• MDR Text Key: 223357579
• Report Number: 2023826-2020-03119
• Device Sequence Number: 1
• Product Code: MTA
• Combination Product (y/n): N
• PMA/PMN Number: NA#S-P#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: 11/24/2020

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: 05/31/2022
• Device Model Number: VICMO13.2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2021
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/19/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR