MAUDE Adverse Event Report: AMO MANUFACTURING USA, LLC WHITESTAR SIGNATURE; UNIT, PHACOFRAGMENTATION

Model Number OPO73

Device Problems Contamination (1120); Use of Device Problem (1670)

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

Event Type  malfunction  

Manufacturer Narrative

Additional narrative information: the sample was discarded at customer site and there was no sample return.Reportedly the concomitant products were: opor3020l (lot# unknown), opohf20l (lot# unknown), ellips fx handpiece (serial# unknown), and signature pro (serial# (b)(4)).Sales rep also obtained image of returned sample.It was alleged that the foreign matter was attached to the gauze and circled.No further information was provided.Section a2, a3,a4,a5: unknown/ not provided.Section b3: date of event: unknown/ not provided.Section e1: email address: unknown; requested but not provided.Section e1: telephone number: (b)(6).Section h3: h-81: a review of records related to the device including labeling, complaint trending, and risk documentation will be performed.Upon completion of this review, if there is any further relevant information obtained, a supplemental medwatch will be filed.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that foreign matter, which looked like a piece of soft plastic (was transparent but was tangible), was found in the patient's eye.It was said this was the third procedure of the day.The doctor extracted the foreign matter from the patient's eye prior the iol implantation and the procedure was successfully completed.There was no patient injury.It was also reported that, ifu (instruction for use) was not followed as the single use opo73 phaco tubing that was used had been used in multiple procedures.

Manufacturer Narrative

Investigation results: a foam swab and a particle sample attached to medical gauze was returned within a sealed plastic pouch.No phaco tubing pack was returned.A visual inspection of the returned sample reveals a translucent particle fixed to medical gauze with office tape.The material characteristics of the returned particle cannot be determined.No suspect products were returned.The origin of the particle cannot be determined.A video of the procedure was provided.Analysis of the video indicated that a particle was removed from the outside surface of the eye with forceps.Due to the quality of the video, whether the particle was ever inside the eye cannot be determined.The reported event was not confirmed.The material was sent to an external lab for further investigation.Ftir analysis confirmed that the foreign material is a plasticized vinyl resin similar to pvc.Refer to external investigation link for additional information.Per follow up with manufacturing supplier quality, pvc is material used in the manufacturing of the collection bag, drip chamber, double lumen (i/a tubing) and the irrigation tubing of opo73.Per dhr no related deviation, ncmr, nc or capa was initiated during the manufacturing process of the reported lot#.All devices meet material, assembly, and performance specifications at the time of product release.Based on the information obtained, since the product was not received for evaluation and the origin of the foreign material cannot be determined, product malfunction and deficiency cannot be confirmed.Johnson & johnson surgical vision will continue to monitor this type of complaints per global complaint trending (sop301064).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Additional information: additional information was received and it was learnt that the video was reviewed and it was observed that forceps were used to extract the alleged foreign matter; however, the video was blur and was difficult to confirm details.Section h6: 4112, 3233, 11 was added.Please note that the information reported in sections d2 (common device name), h.6 (health effect -clinical code and medical device problem code) and section g.1 (manufacturer contact e-mail) is information that remains unchanged from the initial emdr report.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: WHITESTAR SIGNATURE
• Type of Device: UNIT, PHACOFRAGMENTATION
• Manufacturer (Section D): AMO MANUFACTURING USA, LLC; 510 cottonwood drive; milpitas CA 95035
• Manufacturer Contact: somyata nagpal ; 31 technology drive; irvine, CA 92618 ; 7142478552
• MDR Report Key: 16914362
• MDR Text Key: 315040318
• Report Number: 3012236936-2023-01208
• Device Sequence Number: 1
• Product Code: HQC
• UDI-Device Identifier: 15050474602080
• UDI-Public: (01)15050474602080(17)251105(10)60410144
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/17/2023

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: OPO73
• Device Catalogue Number: OPO73
• Device Lot Number: 60410144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2023
• Initial Date FDA Received: 05/11/2023
• Supplement Dates Manufacturer Received: 05/12/2023; 07/24/2023
• Supplement Dates FDA Received: 06/06/2023; 08/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 201977293, OPOR3020L, OPOHF20L, 690880