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. Additional information received indicates no issue with lens prior to use. No further information provided.

Manufacturer Narrative

Corrected data: the following statement was inadvertently not included in the event description of the initial mdr; this report pertains to the second patient's issue who received the lens in the right eye (od). A separate report has been submitted for the first patient's issue who received the lens in the left eye (os). Additional information: additional information obtained confirmed that there were two (2) patients with two different lenses involved. It was clarified 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 field was updated accordingly: device available for evaluation? yes; returned to manufacturer on: 12/03/2019. Device returned to manufacturer? yes. Device evaluation: the sample, only 1mtec30 cartridge was received at the manufacturing site for evaluation. The debris particle was not returned. Visual inspection using magnification was performed to the returned sample: the 1mtec30 cartridge lot number ce02001 returned inside a plastic bag. Residues of viscoelastic material was observed on cartridge for lot number ce02001. No damaged was observed to this cartridge. The photos provided were also evaluated. It was observed a lens implanted in patient eye. One circle is showing the debris in question. However, it is visually impossible to identify through the photo provided, the material and origin of the debris/particle in question. Based on the evidence observed and since the debris/particle is not available for a thoroughly evaluation, the complaint issue reported could not be verified. Based on the analyzed of the returned, there is no indication of a product quality deficiency. Manufacturing records review: the manufacturing process record was evaluated, and the devices were manufactured within specifications. There is no associated deviation or non-conformity report found in the manufacturing record review (mrr). The units were released according to specification with the product intended use as required. A search in complaint system revealed no additional investigation requests for 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: 9386101
• Report Number: 2648035-2019-01265
• 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: 01/01/2005,11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/14/2020
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• 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
• Event Location: No Information
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 10/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Treatment(s): LENS MODEL AAB00 SN: (B)(6)