MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. ELLIPS FX PHACO HANDPIECE; UNIT, PHACOFRAGMENTATION

Model Number 690880

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Keratitis (1944); Eye Burn (2523)

Event Type  Injury  

Manufacturer Narrative

Unknown/ not provided.Date of event is unknown as it was provided.Email address: unknown/not provided.Initial reporter telephone number: (b)(6).An attempt has been made to obtain missing information; however, to date, no response has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

A hospital reported a cataract patient experienced damage to the endothelium as a result of a corneal burn with the use of a compact intutiv system and ellips fx phaco handpiece.Although, the cataract procedure was completed and the lens was implanted in the capsular bag, it was reported surgical intervention was required.In addition, the injury to the damage endothelium may have caused keratitis.Attempts were made to obtain additional information; however, no further information is provided.This report is for the ellips fx phaco handpiece.A separate report will be submitted for compact intutiv system.

Manufacturer Narrative

In initial report, the device evaluation was omitted inadvertently.The following sections were updated according: h3: correction: device evaluated by manufacturer should have been selected as yes h6: correction: type of investigation should have been selected as code 4117 h6: correction: investigation findings should have been selected as code 213 h6: correction: in initial report, device evaluation conclusion code inadvertently provided as code 11 - conclusion not yet available, however, the conclusion code should have been code 67.Was performed.H10-narrative: device evaluation: the product testing could not be performed as the product was not returned.Manufacturing record evaluation: a review of the device history record (dhr) showed that there were no issues or non-conformances during manufacturing.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.Since the sample of the complaint product was not returned, and serial number is unknown, it is not possible to determine a malfunction and/or product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: ELLIPS FX PHACO HANDPIECE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 11455710
• MDR Text Key: 238938798
• Report Number: 2020664-2021-07013
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 05050474537132
• UDI-Public: (01)05050474537132
• Combination Product (y/n): N
• PMA/PMN Number: K981116
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/12/2021

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 Model Number: 690880
• Device Catalogue Number: 690880
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/10/2021
• Supplement Dates Manufacturer Received: 04/15/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COMPACT INTUTIV SN. (B)(6); COMPACT INTUTIV SN. (B)(4)
• Patient Outcome(s): Required Intervention