MAUDE Adverse Event Report: LIFECORE BIOMEDICAL, LLC PROVISC OPHTHALMIC VISCOSURGICAL DEVICE; AID, SURGICAL, VISCOELASTIC

Catalog Number	0004510129
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.This is second of three reports for this reported event.(b)(4).
Event or Problem Description
A nurse reported that a patient experienced toxic anterior segment syndrome (tass).Procedure details and patient impact have not been provided.Additional information has been requested.Additional information received indicated that after a cataract surgery, the patient experienced tass in the right eye.The patient had no surgical complications.The patient presented post-operatively with no signs of symptoms.Upon examination of the patient, the surgeon noted 4+ aqueous cell.The patient was prescribed with post-operative antibiotic and steroid eye drops.No cultures were performed.The patient's outcome was unknown.This file represent the first patient of three from this facility.
Additional Manufacturer Narrative
No valid lot code or sample provided.No further evaluation or root cause analysis can be conducted at this time.No root cause could be determined as no sample or valid lot code was provided for analysis.No action is warranted.The manufacturer internal reference number is: (b)(4).
Additional Manufacturer Narrative
Complaint trending reviewed for the lot code provided.One similar complaint found.There was no sample returned for evaluation.The complaint condition could not be confirmed.Batch records were reviewed and all testing results met specifications for this lot code at the time of release.Additionally, there were no deviations noted during batch record review.Review of the batch record indicates the product meets specification.No manufacturing assignable root cause could be determined.There is no impact to safety, quality, or efficacy of the product.Since the root cause is likely not related to the manufacturing process and the report does not indicate a trend, no further actions are recommended at this time.Quality assurance will continue to monitor and trend complaints of this type.The manufacturer internal reference number is: (b)(4).

• Brand Name: PROVISC OPHTHALMIC VISCOSURGICAL DEVICE
• Common Device Name: AID, SURGICAL, VISCOELASTIC
• Manufacturer (Section D): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• Manufacturer (Section G): LIFECORE BIOMEDICAL, LLC; 3515 lyman boulevard; chaska MN 55318
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 12763859
• Report Number: 2184002-2021-00015
• Device Sequence Number: 11799977
• Product Code: LZP
• UDI-Device Identifier: 00380651830851
• UDI-Public: 00380651830851
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P890047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 0004510129
• Device Lot Number: 029018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/11/2021
• Supplement Date Received by Manufacturer: 11/23/2021; 12/16/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 12/14/2021; 12/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BSS IRRIGATING SOLUTION; ILEVRO DROPS; OFLOXACIN; POVIDONE IODINE 5%; RAY ONE ASPHERIC IOL 19.0 D; VANCOMYCIN IN BSS
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Sex: Female