MAUDE Adverse Event Report: AMO UPPSALA AB HEALON GV PRO; OVDS

Model Number TG85ML

Device Problem Contamination (1120)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

Section age, weight, ethnicity: information unknown, not provided.If implanted; give date: n/a.The healon gv pro is not an implantable device.If explanted; give date: n/a.The healon gv pro is not an implantable device; therefore, not explanted.(b)(6).All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that after relaunch of healon gv pro different surgeons have seen small white "pieces" in eyes after injection of healon gv pro.Every time these white pieces came out during phaco or irrigation/ aspiration steps (i/a).There is no report of these white pieces inside the eye post operatively.No adverse effects to the patients were reported.This has occurred several times after relaunch, no exact details available.No additional information was provided.

Manufacturer Narrative

Additional information: section d9.Device available for evaluation? yes returned to manufacturer on: 2/26/2021 section h3.Device evaluated to manufacturer? yes device evaluation: a visual inspection was performed, and reported white particles were confirmed.The visual assessment of the white/colorless particles, their morphology, position where observed and similar historical observations, indicates that the material is cellidor which is an organic, thermoplastic cellulose ester used to manufacture the plastic holders.Manufacturing records review: per the device history records no related deviation, ncmr ( non-conformance material report ), nc ( non-conformance ) or capa (corrective action preventive action ) was initiated during the manufacturing process of the reported lot#.All devices meet material, assembly, and performance specifications at the time of product release.A search for related complaints from lot number uh31302 from the last 12 months was conducted.No related complaints found.A review of the complaint trending report tr-a-iol-2020.12 from dec 2020 indicates there is no indication of a upward trend in for the device code dc-foreign material-loose and no breech of the upper control limit for complaints of the healon pro products.Additionally, the trending of this specific type of complaint indicates that there is no upward trend observed during 2020/2021 and therefore no need for updating of risk files nor initiating an internal nc/capa.Conclusion: as the source of the material finds is from the manufacturing of the holders at amo uppsala¿s supplier, a supplier non- conformance ( nc ) has previously been initiated for this issue nr-0154388: ¿this nc has currently status for investigation and was started to document the supplier investigation.From the beginning an internal nc was documented because of a large amount of scrapping due to particles on holders with article number corresponding to transport package bag¿.The holders used in manufacturing healon gv batch uh31302 origins from the same manufacturer but has another article number corresponding transport package tray.All pertinent information available to johnson and johnson surgical vision, inc.Has been submitted.

• Brand Name: HEALON GV PRO
• Type of Device: OVDS
• Manufacturer (Section D): AMO UPPSALA AB; rapsgatan 7; uppsala 754 5 0; SW 754 50
• MDR Report Key: 11181256
• MDR Text Key: 230452320
• Report Number: 3004750704-2021-07004
• Device Sequence Number: 1
• Product Code: LZP
• UDI-Device Identifier: 05050474651609
• UDI-Public: (01)05050474651609(17)230531(10)UH31302
• Combination Product (y/n): N
• PMA/PMN Number: P810031
• 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: 04/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• 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: TG85ML
• Device Catalogue Number: 10270014
• Device Lot Number: UH31302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1