MAUDE Adverse Event Report: AMO PUERTO RICO MFG. INC. UNK_CARTRIDGE; LENS, GUIDE, INTRAOCULAR

Model Number UNK-CARTRIDGE

Device Problem Contamination (1120)

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

Event Type  malfunction  

Manufacturer Narrative

Analysis of the complaint device cannot be completed.A review of the device history record, complaint trending, and risk documentation for this device will be performed.Upon completion of the review, if there is any further relevant information a supplemental medwatch will be filed.Attempts have been made to obtain the missing information as well as additional information regarding the event; however, to date, no information has been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that once the intraocular lens (iol) was implanted into the capsular bag, the surgeon noticed the presence of residual particles behind the iol.The surgeon had to take the extra measure of flushing balanced salt solution (bss) behind the optical surface to move the particles in a position to be able to extract with irrigation/aspiration (i/a) hand tool.The surgeon was unsure if the material is biodegradable or not; because of the uncertainty, the surgeon removed the material from the operative eye.The surgeon feels it has something to do with the cartridge.The doctor will continue to observe these cases, then provide more feedback over time.No patient injury was reported and patient outcome is unknown.No further information is available.

• Brand Name: UNK_CARTRIDGE
• Type of Device: LENS, GUIDE, INTRAOCULAR
• Manufacturer (Section D): AMO PUERTO RICO MFG. INC.; road 402 north, anasco ind. pk; anasco PR 00610
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 15090090
• MDR Text Key: 304014605
• Report Number: 3012236936-2022-01975
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Public: (01)(10)UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961242
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2022

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 Model Number: UNK-CARTRIDGE
• Device Catalogue Number: UNK-CARTRIDGE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTRAOCULAR LENS, MODEL/SERIAL: UNKNOWN