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

Model Number	1MTEC30
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If explanted; give date: not applicable, lens remains implanted.Device evaluation: the product testing could not be performed as the product was not returned (the lens remains implanted).The reported complaint cannot be confirmed.Manufacturing record review: the manufacturing process record was evaluated, and no deviation was found during process related to the complaint event reported.The product was manufactured and released according to specifications.A search in complaint system revealed that no other complaints have been received for this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson and johnson surgical vision has been submitted.
Event or Problem Description
It was reported that the doctor noticed something sticky on the back side of the intraocular lens (iol) implanted in a patient's right eye.The substance was difficult to remove, but they were able to pull it off the iol, so it was clearly stuck to it before the iol was inserted.The doctor was able to keep the same lens in the patient's eye and did not have any other issues.Reportedly, the scrub tech did not see anything on the lens but it was noted that the substance was so small that it could not be seen unless under a microscope.They did not see anything on the cartridge before the surgery.They sent the foreign substance to pathology; however, it was later indicated that the specimen retrieved which was a very tiny piece did not survive processing at the pathology lab.It was noted that the concomitant device, cartridge was also discarded by the account.There was no vitrectomy or incision enlargement required and no sutures were used.There was no patient injury reported.It was confirmed that the patient was fine and not effected.No further information was provided.
Additional Manufacturer Narrative
Additional information: additional information indicated that the complaint product may be the cartridge and not the lens.Corrected information: the following fields were updated accordingly as the cartridge was indicated to be the potential complaint device: section d1: brand name: platinum 1 series section d2: product code: kyb section d3: common device name: surgical adjuncts section d4: model #: 1mtec30 section d4: catalog #: 1mtec30 section d4: lot#: ch03080 section d4: expiration date: 2/12/2021 section d4: unique identifier: (b)(4).Section d6: implant date: not applicable as the cartridge is not an implantable device.Section d7: explant date: not applicable as the cartridge is not an implantable device.Section d11: concomitant medical products: tecnis symfony lens, model zxr00, sn: (b)(4).Section g5: pma/510(k) #: k081545 section h4: device manufacture date: 2/12/2020 device evaluation: the product testing could not be performed as the product was not returned for evaluation.The reported complaint cannot be confirmed.Manufacturing records review: the manufacturing records and related documents for the production order of the device were reviewed and no deviations or discrepancies were found during the mrr (manufacturing record review).The units were manufactured and released according to specifications.A search in complaint system revealed that no additional complaint was received from this production order number.Conclusion: as a result of the investigation there is no indication of a product quality deficiency and the reported issue could not be verified.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.

• Brand Name: PLATINUM 1 SERIES
• Common Device Name: SURGICAL ADJUNCTS
• Manufacturer (Section D): JOHNSON & JOHNSON SURGICAL VISION, INC.; 1700 e st andrew place; santa ana CA 92705
• MDR Report Key: 10544914
• Report Number: 2648035-2020-00692
• Device Sequence Number: 19458881
• Product Code: KYB
• UDI-Device Identifier: 05050474579071
• UDI-Public: (01)05050474579071(17)240201
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K081545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: 1MTEC30
• Device Catalogue Number: 1MTEC30
• Device Lot Number: CH03080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2020
• Supplement Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 10/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTRIDGE, MODEL 1MTEC30, LOT# CH03080; TECNIS SYMFONY LENS, MODEL ZXR00, SN (B)(4).; CARTRIDGE, MODEL 1MTEC30, LOT# CH03080
• Patient Age: 71 YR