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

Model Number VICMO 12.1

Device Problem No Apparent Adverse Event (3189)

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

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Weight: unk.Ethnicity: unk.Race: unk.(expiration date): unk, no serial number reported.Pma/510k: this product is not marketed in the us.(device manufacturing date): unk, no serial number reported.(b)(4).

Event Description

The reporter indicated that a 12.1mm, vicmo12.1, -18.00 diopter, implantable collamer lens tore/broke before/during loading.It was reported that the damage was noted "after injected".Patient contact is unknown.Additional information has been requested but none has been forthcoming.If additional information is received a supplemental medwatch report will be submitted.

Manufacturer Narrative

Additional information: h3-device evaluation: lens returned in a micro-centrifuge vial with moisture and residue/debris on product.Visual inspection found haptic torn and residue and debris on lens.Claim# (b)(4).

Manufacturer Narrative

Additional information: b5-the reporter indicated that a 12.1mm vicmo 12.1 implantable collamer lens of -18.00 diopter was broken while loading it on 22-07-2020.Reporter believes "it was while grasping the lens with front loading forceps." there was no patient contact.Corrected data: h6-investigation code 4110: lens work order search: no additional similar complaint type event(s) within associated lots were found.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: 10484165
• MDR Text Key: 216874962
• Report Number: 2023826-2020-02003
• 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: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2020

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 Expiration Date: 05/31/2023
• Device Model Number: VICMO 12.1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 09/02/2020
• Supplement Dates Manufacturer Received: 10/02/2020; 11/30/2020
• Supplement Dates FDA Received: 10/22/2020; 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR