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

Model Number 1VTEC30

Device Problem Contamination (1120)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported that white particles were observed over the lens when it was injected from the cartridge into the patient's eye.The surgeon washed the lens while doing ophthalmic viscoelastic device (ovd) removal, but particles were remained over it.The surgeon noticed that the particles were inside the cartridge and that they did not have a normal luster.It was noted that the cartridge was quite opaque and that with naked eyes particles were not visible at the tip of cartridge.It was indicated that a non-johnson and johnson sodium hyaluronate ovd and balanced salt solution (bss) for irrigation was used.There was no delay in treatment and no medical or surgical interventions required.The lens remains implanted in the eye and reportedly, the patient is good post-operation and can see clearly.There was no patient injury reported.No further information was provided.No further information was provided.

Manufacturer Narrative

Unknown/not provided, information was asked but it was not provided.If implanted; give date: n/a (not applicable).The cartridge is not an implantable device.If explanted; give date: n/a (not applicable).The cartridge is not an implantable device; therefore; not explanted.Concomitant medical products: intraocular lens, model zfr00v -23.5, sn (b)(6) sodium hyaluronate ( cohevisc brand); clearsol bss.Initial reporter telephone number: (b)(6).The device has not returned for evaluation.Therefore, a failure analysis of the complaint device cannot be completed.A review of the device lot 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; however, to date, the information has not been received.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

Section d9: device available for evaluation: yes.Date returned to manufacturer: june 1, 2022.Section h3: device returned to manufacturer: yes.Device evaluation: visual inspection was performed under magnification.The complaint lens presented with particles and debris inside the cartridge body and tip.The cartridge was forwarded to eag laboratories for ftir analysis.Ftir results were compared the manufacturing site component database and no matches exceeded the threshold of 0.9 comparison threshold.The closest comparison match was 0.46 and was 52846-007lens paper 8x12 inches.Eag compared the results to their own materials database and reported that the material appeared to contain methyl cellulose and a salt species similar to sodium hyaluronate.Edx was also performed by eag laboratories and also supported the conclusion of the material containing sodium hyaluronate.Subject matter expert (sme) reviewed the product evaluation and eag results.The sme suggested that the material could be residual non-j&j ovd, which is supported by the information in the complaint.Conclusion: based on complaint investigation results, there is no indication of a product malfunction or product quality deficiency.No nonconformity report, documentation or labeling changes, and escalations are required.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: UNFOLDER PLATINUM
• 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: 14446573
• MDR Text Key: 300309182
• Report Number: 3012236936-2022-01311
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474587533
• UDI-Public: (01)05050474587533(17)230120(10)CK03462
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K081545
• 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
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: 1VTEC30
• Device Catalogue Number: 1VTEC30
• Device Lot Number: CK03462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Male