MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. COMPACT INTUITIV; UNIT, PHACOFRAGMENTATION

Model Number OPO85

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Manufacturer Narrative

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 surgery center reported observing pin like holes worn into the tyvek lid of a compact intutiv pack multi use tubing set model opo85.The observation was made prior to use and during handling, therefore, the tubing pack was not used.The surgery center had concerned the packaging had been comprised and the tubing pack was no longer sterile.

Manufacturer Narrative

Device evaluation: the device was not returned at the manufacturing site; therefore, product testing could not be performed and the customer¿s reported complaint could not be verified.Manufacturing record review: a record review was performed.A product deficiency review was performed and there is no product deficiency identified.A document, lot history, and trending were reviewed.There is not a recognizable adverse trend.The risks and mitigations associated with the complaint issue are identified in existing risk documents and no new risks were identified as part of this investigation.The review of the device history record (dhr) for the opo tubing pack showed that there were no issues or non-conformities.The device and its components met all specifications prior to being released.Manufacturing has been ruled out as a potential cause for the reported issue.Based on the investigation results, no corrective action has been issued.Conclusion: based on the information obtained, product malfunction and product deficiency cannot be confirmed.No further investigation is required all pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: COMPACT INTUITIV
• 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: 11700265
• MDR Text Key: 246463744
• Report Number: 2020664-2021-07026
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 35050474573360
• UDI-Public: (01)35050474573360(17)230801(10)60251455
• Combination Product (y/n): N
• PMA/PMN Number: K151783
• 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: 09/08/2021

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: 08/01/2023
• Device Model Number: OPO85
• Device Lot Number: 60251455
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/24/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 08/17/2021
• Supplement Dates FDA Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1