MAUDE Adverse Event Report: JOHNSON & JOHNSON SURGICAL VISION, INC. PLATINUM 1 SERIES; SURGICAL ADJUNCTS

Model Number 1MTEC30

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

Age/date of birth: unknown/ not provided.Sex/gender: unknown/ 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.Phone number: (b)(6).All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Event Description

It was reported that during surgery, a silk-like substance in the eye followed by the intraocular lens (iol) implant.The silk-like substance was able to be removed with the ophthalmic viscosurgical device (ovd) at the ending stage of the procedure.The doctor thinks that the silk-like substance may have come from the cartridge.No surgical interventions such as vitrectomy, incision enlargement or sutures were required.No additional information was provided.

Manufacturer Narrative

Additional information obtained indicated that the customer is not sure about where the silk-like substance is from.It was confirmed that there were two (2) patients with two different lenses involved which this report pertains to the patient who received the monofocal intraocular lens, model aab00, sn (b)(4) (the concomitant product) in the left eye (os).It was indicated that the cartridge was available.Additionally, it was confirmed that the doctor checked the lens by microscope when he put the iol into the cartridge which it was clear and there was no issue with the lens prior to use.Then the doctor turned plunger to push out the iol and he found the silk-like substance.It was noted that the same cartridge model, different lots were used by the doctor on both patients with the same reported issue.The following fields were updated accordingly: this report pertains to the first patient's issue who received the lens in the left eye (os).A separate report has been submitted for the 2nd patient who received the lens in the right eye (od).Concomitant medical products: monofocal lens, model aab00, sn (b)(4).Device available for evaluation? yes; returned to manufacturer on: 12/03/2019.Device returned to manufacturer? yes.Device evaluation: the product was received in a plastic bag at the manufacturing site for evaluation.The sample was received with three additional cartridges in the same bag (one with lot number ce02001 and two with lot number ce02738).The reported foreign mater was not returned.The evaluation/visual inspection at microscope magnification was performed for the suspect product with lot number ce02739: lubricant material residues and loose particles can be observed in the complaint cartridge.There was no damaged or defect observed on the cartridge.The photos provided were also evaluated.The photos show a lens implanted into the patient¿s eye.There is a circle which pointing the foreign mater in question.However, through photos it is not possible to identify what the material is or where it comes from.Therefore, the reported issue could not be verified, and product quality deficiency could not be determined.Manufacturing records review: the manufacturing record review was performed and no non conformance reports, no deviations and no discrepancies found during the mrr (manufacturing record review).The product was manufactured and released according to specifications.A search in complaint history revealed that no additional complaints were received from this production order number.Conclusion: as a result of the investigation, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

Manufacturer Narrative

This correction mdr is being submitted to address inaccurate information in section f on the xml version of the previous submission caused by a software glitch in the transmission process.The internal non-conformance numbers for this software issue are (b)(4) and capa-010215.

• Brand Name: PLATINUM 1 SERIES
• Type of Device: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 9332162
• MDR Text Key: 178747597
• Report Number: 2648035-2019-01213
• Device Sequence Number: 1
• Product Code: KYB
• UDI-Device Identifier: 05050474540323
• UDI-Public: (01)05050474540323(17)200314(10)CE02739
• Combination Product (y/n): Y
• PMA/PMN Number: K081545
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CE02739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AAB00 LENS SN (B)(6).