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

Model Number VICMO12.6

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/22/2021

Event Type  malfunction  

Manufacturer Narrative

Pt info: unk.Pma/510(k): this product is manufactured in the u.S.But not marketed in the u.S.Investigation type 4110: lens work order search-no similar complaint type events reported for units within the same lot.Claim# (b)(4).

Event Description

The reporter indicated that a 12.6mm vicmo12.6 implantable collamer lens diopter -9.5 had foreign matter attached to the optical zone of the lens.There was no patient contact with the lens.This occurred on (b)(6) 2021.An alternate lens was successfully implanted at a later date and the problem is resolved.

Manufacturer Narrative

H3-device evaluation: the lens was returned with moisture in a micro-centrifuge vial.There was residue on the product.Visual inspection found no visible damage to the lens and foreign material on the lens.Particulate was noted on the optic of the lens.Claim# (b)(4).

Manufacturer Narrative

H6-investigation code 3331: device history record (dhr) review-based on the results of the investigation, the piece of collamer is likely excess collamer material left over from the machining process.However, we were unable to determine a definitive root cause for this event.Operators involved in the manufacturing of this nonconforming lens have been retrained and made aware of the importance of verifying that no particulates are present on the lens.There is no indication that suggests a deficiency in the manufacturing process or a trend of process errors.Further investigation or action is not required at this time.Claim# (b)(4).

• Brand Name: IMPLANTABLE COLLAMER LENS
• Type of Device: PHAKIC INTRAOCULAR LENS
• Manufacturer (Section D): STAAR SURGICAL COMPANY; 1911 walker avenue; monrovia CA 91016
• MDR Report Key: 12378624
• MDR Text Key: 268511854
• Report Number: 2023826-2021-03364
• 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,Followup
• Report Date: 08/01/2021

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: 05/31/2024
• Device Model Number: VICMO12.6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Manufacturer Received: 08/01/2021
• Initial Date FDA Received: 08/27/2021
• Supplement Dates Manufacturer Received: 09/08/2021; 09/28/2021
• Supplement Dates FDA Received: 09/30/2021; 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR