MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. COMPACT INTUITIV PACK DISPOSABLE TUBING SET; PHACO TUBING

Model Number OPO80

Device Problems Restricted Flow rate (1248); Inability to Irrigate (1337)

Patient Problems Corneal Edema (1791); Eye Burn (2523)

Event Date 06/03/2020

Event Type  Injury  

Manufacturer Narrative

Lot no.Is unknown as it was not provided.Unique identifier (udi #) is unknown as lot no.Was not provided (b)(6).Manufacturer date is unknown as lot no was not provided.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

During a cataract extraction procedure, a thermal burn and edema occurred in the patient¿s operative eye when using the opo80- compact intuitiv pack disposable tubing set.A brief description from the surgery center indicated the phaco tip was inserted into patient¿s eye and applied, lots of bubbles expelled.One side of irrigation seemed not flowing, and slight thermal burn occurred.The wound was sutured to close.The procedure was delayed for approximately 20 minutes.

Manufacturer Narrative

Section d10.Device available for evaluation? yes.Returned to manufacturer on: 7/01/2020.Section h3.Device returned to manufacturer? yes.Device evaluation: the opo80 tubing pack was as received without its tyvek lid, and lot# cannot be obtained.A visual inspection of the returned product did not reveal any debris, loose particles, fibers or damage/defects.All functional tests were performed, and results were found within specifications.The returned pack functioned as intended.The reported issue could not be confirmed.A video of the reported issue was provided to johnson & johnson surgical vision medical affair for review.Per medical affair team, ¿the whitening (whitening circular pattern) observed in the main wound that appeared after the phaco procedure was started, seems to be compatible with a wound thermal injury.The edema seems to be more associated to the multiple attempts to close the incision through stromal hydration prior to the corneal suture.Since the observation (thermal injury) was located where the phaco probe entered the eye anterior chamber, the most probable cause of the issue was an overheating of the probe tip.Such observation may be associated to an insufficient or unbalanced irrigation aspiration, either insufficient or unbalanced irrigation aspiration may be multifactorial.¿ return phaco pack opo80 was tested for irrigation flow rate, aspiration flow rate, and also vacuum, however, all results were found within specifications.Based on the information obtained, product malfunction cannot be confirmed.Manufacturing record review: the opo80, lot# was not provided and cannot be obtained based on reported information.Therefore, manufacturer record review and complaint history review cannot be performed.Conclusion: based on the investigation results there is no indication of a product quality deficiency.Johnson & johnson surgical vision will continue to monitor this type of complaints.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.H3 other text : placeholder.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are nr-0148919 and capa-010215.

• Brand Name: COMPACT INTUITIV PACK DISPOSABLE TUBING SET
• Type of Device: PHACO TUBING
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10232836
• MDR Text Key: 197567777
• Report Number: 3006695864-2020-00311
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): Y
• PMA/PMN Number: K060366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPO80
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TIP, HANDPIECE; TIP, HANDPIECE
• Patient Outcome(s): Required Intervention