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

Catalog Number N/A

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Product code: unk (esubmitter software does not allow for a blank or 'unk' entry).This product is not marketed in the us.(b)(4).

Event Description

A implantable collamer lens was returned with additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

H3- device evaluation : lens was returned with moisture, in a microcentrifuge vial.Visual inspection found a damage lens ( torn optic and haptic).Claim# (b)(4).

Manufacturer Narrative

Claim#: (b)(4).

Manufacturer Narrative

Corrected data: b5 - a implantable collamer lens was returned with damage.Additional information has been requested but no information has been provided.If additional information is received a supplemental medwatch report will be submitted.G4 - date in initial medwatch report should be corrected to (b)(6) 2020.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
• MDR Report Key: 10308809
• MDR Text Key: 201888144
• Report Number: 2023826-2020-01528
• 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,Followup
• Report Date: 06/29/2020

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 Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/22/2020
• Supplement Dates Manufacturer Received: 06/29/2020; 01/04/2021; 01/06/2021
• Supplement Dates FDA Received: 09/19/2020; 01/04/2021; 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1